Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women (H4HW)
28. März 2022 aktualisiert von: Susana Cristina Araújo Póvoas, University Institute of Maia
Effects of a Short- and Long-term Team Handball-based Exercise Programme on Physical Fitness and Health Status of Inactive Postmenopausal Women
This study aimed at determining the short- (16 weeks) and long-term (36 weeks) health and physical fitness effects and adherence of recreational team handball training for postmenopausal women without previous experience with the sport.
The investigators hypothesized that short-term recreational team handball training would result in positive health and physical fitness adaptations and that the health and physical fitness improvements achieved after the first 16 weeks would be maintained or further improved at the long-term. Moreover, the investigators also hypothesized that the adherence to this exercise mode would be maintained throughout the 36 weeks (long-term) compared to the first 16 weeks (short-term).
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
80
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Porto
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Maia, Porto, Portugal, 4476-690
- University of Maia
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion Criteria:
- Inactive postmenopausal women aged +55 years or younger if with menopause for at least 3 years
Exclusion Criteria:
- Any medical contraindications to perform moderate-to-vigorous physical activity
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Team handball group
The team handball group participants were encouraged to performed at least two out of three weekly supervised team handball training sessions of 60 min each, for 36 weeks.
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Two to three weekly sessions of recreational team handball training for 36 weeks.
Each 60-min session started with a standardised warm-up (including running, coordination, strength, flexibility, and balance exercises) followed by three 15-min periods of recreational team handball matches, interspersed by 2-min breaks, played as small-sided games (4v4, 5v5 or 6v6).
The training sessions were performed on an indoor team handball court (40x20 m) adjusted to result in 34-36 m2 per player.
During the matches, the participants rotated positions every 3 min in a random order, including the goalkeeper and no exclusions or substitutions were applied.
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Kein Eingriff: Control group
The control group participants were instructed to keep their regular daily physical activity for 36 weeks.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Between group differences in peak oxygen uptake at week 16
Zeitfenster: Week 16
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Week 16
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Between group differences in peak oxygen uptake at week 36
Zeitfenster: Week 36
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Week 36
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Changes from baseline in peak oxygen uptake at week 16
Zeitfenster: Baseline and week 16
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Baseline and week 16
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Changes from baseline in peak oxygen uptake at week 36
Zeitfenster: Baseline and week 36
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Baseline and week 36
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Changes from week 16 in peak oxygen uptake at week 36
Zeitfenster: Week 16 and week 36
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Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
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Week 16 and week 36
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Between group differences in resting heart rate at week 16
Zeitfenster: Week 16
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Week 16
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Between group differences in resting heart rate at week 36
Zeitfenster: Week 36
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Week 36
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Changes from baseline in resting heart rate at week 16
Zeitfenster: Baseline and week 16
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Baseline and week 16
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Changes from baseline in resting heart rate at week 36
Zeitfenster: Baseline and week 36
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Baseline and week 36
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Changes from week 16 in resting heart rate at week 36
Zeitfenster: Week 16 and week 36
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Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
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Week 16 and week 36
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Between group differences in body mass at week 16
Zeitfenster: Week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16
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Between group differences in body mass at week 36
Zeitfenster: Week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 36
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Changes from baseline in body mass at week 16
Zeitfenster: Baseline and week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 16
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Changes from baseline in body mass at week 36
Zeitfenster: Baseline and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 36
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Changes from week 16 in body mass at week 36
Zeitfenster: Week 16 and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16 and week 36
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Between group differences in fat mass at week 16
Zeitfenster: Week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16
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Between group differences in fat mass at week 36
Zeitfenster: Week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 36
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Changes from baseline in fat mass at week 16
Zeitfenster: Baseline and week 16
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 16
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Changes from baseline in fat mass at week 36
Zeitfenster: Baseline and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 36
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Changes from week 16 in fat mass at week 36
Zeitfenster: Week 16 and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16 and week 36
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Between group differences in lean mass at week 16
Zeitfenster: Week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
|
Week 16
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Between group differences in lean mass at week 36
Zeitfenster: Week 36
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 36
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Changes from baseline in lean mass at week 16
Zeitfenster: Baseline and week 16
|
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 16
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Changes from baseline in lean mass at week 36
Zeitfenster: Baseline and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Baseline and week 36
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Changes from week 16 in lean mass at week 36
Zeitfenster: Week 16 and week 36
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Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
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Week 16 and week 36
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Between group differences in lumbar spine bone mineral density at week 16
Zeitfenster: Week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in lumbar spine bone mineral density at week 36
Zeitfenster: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in lumbar spine bone mineral density at week 16
Zeitfenster: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in lumbar spine bone mineral density at week 36
Zeitfenster: Baseline and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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Changes from week 16 in lumbar spine bone mineral density at week 36
Zeitfenster: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
|
|
Between group differences in dominant femur bone mineral density at week 16
Zeitfenster: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
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Between group differences in dominant femur bone mineral density at week 36
Zeitfenster: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 36
|
|
Changes from baseline in dominant femur bone mineral density at week 16
Zeitfenster: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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|
Changes from baseline in dominant femur bone mineral density at week 36
Zeitfenster: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
|
Changes from week 16 in dominant femur bone mineral density at week 36
Zeitfenster: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in dominant femoral neck bone mineral density at week 16
Zeitfenster: Week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16
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Between group differences in dominant femoral neck bone mineral density at week 36
Zeitfenster: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in dominant femoral neck bone mineral density at week 16
Zeitfenster: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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|
Changes from baseline in dominant femoral neck bone mineral density at week 36
Zeitfenster: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
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Changes from week 16 in dominant femoral neck bone mineral density at week 36
Zeitfenster: Week 16 and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in lumbar spine bone mineral content at week 16
Zeitfenster: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in lumbar spine bone mineral content at week 36
Zeitfenster: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in lumbar spine bone mineral content at week 16
Zeitfenster: Baseline and week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in lumbar spine bone mineral content at week 36
Zeitfenster: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
|
|
Changes from week 16 in lumbar spine bone mineral content at week 36
Zeitfenster: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
|
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Between group differences in dominant femur bone mineral content at week 16
Zeitfenster: Week 16
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
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Between group differences in dominant femur bone mineral content at week 36
Zeitfenster: Week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
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Changes from baseline in dominant femur bone mineral content at week 16
Zeitfenster: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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Changes from baseline in dominant femur bone mineral content at week 36
Zeitfenster: Baseline and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 36
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|
Changes from week 16 in dominant femur bone mineral content at week 36
Zeitfenster: Week 16 and week 36
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16 and week 36
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Between group differences in dominant femoral neck bone mineral content at week 16
Zeitfenster: Week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 16
|
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Between group differences in dominant femoral neck bone mineral content at week 36
Zeitfenster: Week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Week 36
|
|
Changes from baseline in dominant femoral neck bone mineral content at week 16
Zeitfenster: Baseline and week 16
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Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
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Baseline and week 16
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|
Changes from baseline in dominant femoral neck bone mineral content at week 36
Zeitfenster: Baseline and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Baseline and week 36
|
|
Changes from week 16 in dominant femoral neck bone mineral content at week 36
Zeitfenster: Week 16 and week 36
|
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
|
Week 16 and week 36
|
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Between group differences in osteocalcin at week 16
Zeitfenster: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
|
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Between group differences in osteocalcin at week 36
Zeitfenster: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
|
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Changes from baseline in osteocalcin at week 16
Zeitfenster: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
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Changes from baseline in osteocalcin at week 36
Zeitfenster: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 36
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Changes from week 16 in osteocalcin at week 36
Zeitfenster: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
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Between group differences in procollagen type-1 amino-terminal propeptide at week 16
Zeitfenster: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
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Between group differences in procollagen type-1 amino-terminal propeptide at week 36
Zeitfenster: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
|
|
Changes from baseline in procollagen type-1 amino-terminal propeptide at week 16
Zeitfenster: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
|
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Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36
Zeitfenster: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
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Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36
Zeitfenster: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16 and week 36
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Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16
Zeitfenster: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
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Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36
Zeitfenster: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
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|
Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16
Zeitfenster: Baseline and week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 16
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Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36
Zeitfenster: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
|
|
Changes from week 16 in carboxy-terminal type-1 collagen crosslinks at week 36
Zeitfenster: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16 and week 36
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Between group differences in sclerostin at week 16
Zeitfenster: Week 16
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 16
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Between group differences in sclerostin at week 36
Zeitfenster: Week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Week 36
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Changes from baseline in sclerostin at week 16
Zeitfenster: Baseline and week 16
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Determined by chemiluminescence method using a fully automated immunoassay system.
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Baseline and week 16
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Changes from baseline in sclerostin at week 36
Zeitfenster: Baseline and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
|
Baseline and week 36
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Changes from week 16 in sclerostin at week 36
Zeitfenster: Week 16 and week 36
|
Determined by chemiluminescence method using a fully automated immunoassay system.
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Week 16 and week 36
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Between group differences in isometric knee extension peak torque at week 16
Zeitfenster: Week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 16
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Between group differences in isometric knee extension peak torque at week 36
Zeitfenster: Week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 36
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Changes from baseline in isometric knee extension peak torque at week 16
Zeitfenster: Baseline and week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Baseline and week 16
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Changes from baseline in isometric knee extension peak torque at week 36
Zeitfenster: Baseline and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Baseline and week 36
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Changes from week 16 in isometric knee extension peak torque at week 36
Zeitfenster: Week 16 and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
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Week 16 and week 36
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Between group differences in isometric knee extension rate of force development at week 16
Zeitfenster: Week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16
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Between group differences in isometric knee extension rate of force development at week 36
Zeitfenster: Week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 36
|
|
Changes from baseline in isometric knee extension rate of force development at week 16
Zeitfenster: Baseline and week 16
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Baseline and week 16
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Changes from baseline in isometric knee extension rate of force development at week 36
Zeitfenster: Baseline and week 36
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Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Baseline and week 36
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Changes from week 16 in isometric knee extension rate of force development at week 36
Zeitfenster: Week 16 and week 36
|
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
|
Week 16 and week 36
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Between group differences in upper body strength at week 16
Zeitfenster: Week 16
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Determined by a handgrip dynamometer.
|
Week 16
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Between group differences in upper body strength at week 36
Zeitfenster: Week 36
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Determined by a handgrip dynamometer.
|
Week 36
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Changes from baseline in upper body strength at week 16
Zeitfenster: Baseline and week 16
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Determined by a handgrip dynamometer.
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Baseline and week 16
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Changes from baseline in upper body strength at week 36
Zeitfenster: Baseline and week 36
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Determined by a handgrip dynamometer.
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Baseline and week 36
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Changes from week 16 in upper body strength at week 36
Zeitfenster: Week 16 and week 36
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Determined by a handgrip dynamometer.
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Week 16 and week 36
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Between group differences in postural balance at week 16
Zeitfenster: Week 16
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Determined by the number of falls in a single-legged flamingo balance test.
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Week 16
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Between group differences in postural balance at week 36
Zeitfenster: Week 36
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Determined by the number of falls in a single-legged flamingo balance test.
|
Week 36
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Changes from baseline in postural balance at week 16
Zeitfenster: Baseline and week 16
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Determined by the number of falls in a single-legged flamingo balance test.
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Baseline and week 16
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Changes from baseline in postural balance at week 36
Zeitfenster: Baseline and week 36
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Determined by the number of falls in a single-legged flamingo balance test.
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Baseline and week 36
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Changes from week 16 in postural balance at week 36
Zeitfenster: Week 16 and week 36
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Determined by the number of falls in a single-legged flamingo balance test.
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Week 16 and week 36
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Between group differences in aerobic performance at week 16
Zeitfenster: Week 16
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
|
Week 16
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Between group differences in aerobic performance at week 36
Zeitfenster: Week 36
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
|
Week 36
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Changes from baseline in aerobic performance at week 16
Zeitfenster: Baseline and week 16
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Baseline and week 16
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Changes from baseline in aerobic performance at week 36
Zeitfenster: Baseline and week 36
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Baseline and week 36
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Changes from week 16 in aerobic performance at week 36
Zeitfenster: Week 16 and week 36
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Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
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Week 16 and week 36
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Between group differences in total cholesterol at week 16
Zeitfenster: Week 16
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Determined by an automated analyser.
|
Week 16
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Between group differences in total cholesterol at week 36
Zeitfenster: Week 36
|
Determined by an automated analyser.
|
Week 36
|
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Changes from baseline in total cholesterol at week 16
Zeitfenster: Baseline and week 16
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Determined by an automated analyser.
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Baseline and week 16
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Changes from baseline in total cholesterol at week 36
Zeitfenster: Baseline and week 36
|
Determined by an automated analyser.
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Baseline and week 36
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Changes from week 16 in total cholesterol at week 36
Zeitfenster: Week 16 and week 36
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Determined by an automated analyser.
|
Week 16 and week 36
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Between group differences in high-density lipoprotein cholesterol at week 16
Zeitfenster: Week 16
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Determined by an automated analyser.
|
Week 16
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Between group differences in high-density lipoprotein cholesterol at week 36
Zeitfenster: Week 36
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Determined by an automated analyser.
|
Week 36
|
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Changes from baseline in high-density lipoprotein cholesterol at week 16
Zeitfenster: Baseline and week 16
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Determined by an automated analyser.
|
Baseline and week 16
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Changes from baseline in high-density lipoprotein cholesterol at week 36
Zeitfenster: Baseline and week 36
|
Determined by an automated analyser.
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Baseline and week 36
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Changes from week 16 in high-density lipoprotein cholesterol at week 36
Zeitfenster: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
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Between group differences in low-density lipoprotein cholesterol at week 16
Zeitfenster: Week 16
|
Determined by an automated analyser.
|
Week 16
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Between group differences in low-density lipoprotein cholesterol at week 36
Zeitfenster: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in low-density lipoprotein cholesterol at week 16
Zeitfenster: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
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|
Changes from baseline in low-density lipoprotein cholesterol at week 36
Zeitfenster: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
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Changes from week 16 in low-density lipoprotein cholesterol at week 36
Zeitfenster: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in triglycerides at week 16
Zeitfenster: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in triglycerides at week 36
Zeitfenster: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in triglycerides at week 16
Zeitfenster: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in triglycerides at week 36
Zeitfenster: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in triglycerides at week 36
Zeitfenster: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in fasting glucose at week 16
Zeitfenster: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in fasting glucose at week 36
Zeitfenster: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Changes from baseline in fasting glucose at week 16
Zeitfenster: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in fasting glucose at week 36
Zeitfenster: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in fasting glucose at week 36
Zeitfenster: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in fasting insulin at week 16
Zeitfenster: Week 16
|
Determined by an automated analyser.
|
Week 16
|
|
Between group differences in fasting insulin at week 36
Zeitfenster: Week 36
|
Determined by an automated analyser.
|
Week 36
|
|
Change from baseline in fasting insulin at week 16
Zeitfenster: Baseline and week 16
|
Determined by an automated analyser.
|
Baseline and week 16
|
|
Change from baseline in fasting insulin at week 36
Zeitfenster: Baseline and week 36
|
Determined by an automated analyser.
|
Baseline and week 36
|
|
Change from week 16 in fasting insulin at week 36
Zeitfenster: Week 16 and week 36
|
Determined by an automated analyser.
|
Week 16 and week 36
|
|
Between group differences in glucose tolerance at week 16
Zeitfenster: Week 16
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 16
|
|
Between group differences in glucose tolerance at week 36
Zeitfenster: Week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 36
|
|
Changes from baseline in glucose tolerance at week 16
Zeitfenster: Baseline and week 16
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Baseline and week 16
|
|
Changes from baseline in glucose tolerance at week 36
Zeitfenster: Baseline and week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Baseline and week 36
|
|
Changes from week 16 in glucose tolerance at week 36
Zeitfenster: Week 16 and week 36
|
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
|
Week 16 and week 36
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
2. Januar 2016
Primärer Abschluss (Tatsächlich)
1. März 2018
Studienabschluss (Tatsächlich)
1. März 2018
Studienanmeldedaten
Zuerst eingereicht
14. März 2022
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. März 2022
Zuerst gepostet (Tatsächlich)
23. März 2022
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. April 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. März 2022
Zuletzt verifiziert
1. März 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- CEFADE202019
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .