Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Preventing Diabetic Osteoporosis With Exercise (DIABETICBONE)

26. April 2019 aktualisiert von: Dr. Katarina Borer, University of Michigan

Parameters of Exercise to Prevent Type 2 Diabetic Osteoporosis in Postmenopausal Women

The two specific aims of the study were to determine whether:

  1. Greater mechanical loading of downhill exercise will increase the osteogenic index (ratio between CICP, the marker of bone formation (c-terminal propeptide of type I collagen, and CTX, the marker of bone resorption (c terminal telopeptide of type I collagen)) to a greater extent than uphill exercise that provides lower ground-reaction force;
  2. Exercise after the meals will induce greater osteogenic response than exercise pefore the meals as it is known that meal eating during daytime inhibits bvone resorption markers.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The study addresses the problem that postmenopausal women with type 2 diabetes have a higher incidence of bone breaks despite their often normal bone mineral density (BMD).

The investigators pursued two hypotheses, that:

  1. 40-minute bout of downhill exercise will increase the CICP/CTX osteogenic index to a greater extent than the same amount of uphill exercise; and
  2. Performing exercise one hour after the meals will be more osteogenic than exercise before the meals.

Subjects were 15 postmenopausal women with type 2 diabetes, age 57.7 years, BMI 27.2 kg/m2 who were randomly assigned to two out of 5 trials:

Uphill exercise before the meals (UBM), Uphill exercise after the meals (UAM), Downhill exercise before the meals (DBM), Downhill exercise after the meals (DAM), and Sedentary, no-exercise, trial (SED). All subjects signed an informed consent approved by the University of Michigan Medical School Institutional Review Board. Subjects had their BMD measured with DXA at the outset.

Weight-maintenance meals contained 50% carbohydrate, 15% protein, and 25% fat and were provided at 10 h and 17 h. Exercise (40 minutes at 50% of maximal effort) on either uphill (+6o slope) or downhill treadmill (-6o slope) was performed either before the two meals, at 9 h and 16 h, respectively, or after the meals. at 11 h and 18 h, respectively.

Blood was drawn through an intravenous catheter from ante-cubital vein at hourly intervals between 8 and 20 h with two additional blood draws at 0 h and 6 h the next morning. Blood was treated with protease inhibitors, and plasma, frozen at -80o C, was used to measure bone markers, CICP, CTX, osteocalcin , and bone-specific alkaline phosphatase using Millipore chemoluminescen reagents, glucose by glucose oxidase, and hormones insulin, cortisol, parathyroid hormone (PTH) , and growth hormone (GH) by radio-immunoassays..

Mixed-model ANOVA was used for analysis of outcome measures where the trial procedures served as fixed variable and individual subjects as intercept variables.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

15

Phase

  • Unzutreffend

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

50 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

postmenopausal type-2 diabetes melllitus age between 50 and 65 exercise less than 20 minutes three times a week

Exclusion Criteria:

metabolic disease other than type-2 diabetes and hormonally-corrected hypothyroidism musculo-skeletal disability that would preclude exercise smoker do not meet inclusion criteria

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Uphill exercise before the meals
40 minutes of uphill treadmill exercise at +6o slope completed 1 hour before eating the meal
Kombinationsprodukt: Behavior intervention of uphill exercise
40 minutes of uphill exercise
Kombinationsprodukt: Dietary intervention of exercise before the meal
40 minutes of uphill exercise completed 1 h before the meal
Kombinationsprodukt: Dietary intervention of exercise before the meal
40 minutes of downhill exercise completed 1 hour before the meal
Experimental: Uphill exercise after the meals
40 minutes of uphill treadmill exercise at +6o slope started 1 hour after eating the meal
Kombinationsprodukt: Dietary intervention of uphill exercise
40 minutes of uphill exercise
Kombinationsprodukt: Dietary intervention of exercise after the meal
40 minutes of uphill exercise started 1 hour after gthe meal
Kombinationsprodukt: Dietary intervention of exercise after the meal
40 minutes of downhill exercise started 1 hour after the meal
Experimental: Downhill exercise before the meals
40 minutes of downhill treadmill exercise at -6o slope completed 1 hour before eating the meal
Kombinationsprodukt: Dietary intervention of exercise before the meal
40 minutes of uphill exercise completed 1 h before the meal
Kombinationsprodukt: Dietary intervention of exercise before the meal
40 minutes of downhill exercise completed 1 hour before the meal
Kombinationsprodukt: Behavior intervention of downhill exercise
40 minutes of downhill exercise
Experimental: Downhill exercise after the meals
40 minutes of downhill treadmill exercise at -6o slope started 1 hour after eating the meal
Kombinationsprodukt: Dietary intervention of exercise after the meal
40 minutes of uphill exercise started 1 hour after gthe meal
Kombinationsprodukt: Dietary intervention of exercise after the meal
40 minutes of downhill exercise started 1 hour after the meal
Kombinationsprodukt: Behavioral intervention of downhill exercise
40 minutes of downhill exercise
Schein-Komparator: Sedentary trial
A trial with no exercise
Kombinationsprodukt: Behavioral intervention of sedentary no-exercise trial
Sedentary no-exercise trial
Kombinationsprodukt: Dietary intervention of eating two meals
Meals eaten at 10 and 17 h during a sedentary trial

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
C-terminal propeptide of type I collagen
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of c-terminal propeptde of type 1 collagen (ng/ml)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
C-terminal telopeptide of type 1 collagen
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of c-terminal telopeptide of type 1 collagen (ng/ml)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Osteocalcin
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of osteocalcin (ng/ml)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Bone-specific alkaline phosphatase
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of bone-specific alkaline phosphatase (ng/ml)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Insulin
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of insulin (µU/ml)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Parathyroid hormone
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of parathyroid hormone (ng/ml)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Cortisol
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of cortisol (m/L)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Growth hormone
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of growth hormone (ng/ml)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Glucose
Zeitfenster: Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Change over time in plasma concentration of glucose (mg/dl)
Hourly over 12 hours from the start of the trial, then at 16 hours, and at 22 hours, after the start of the trial
Dual-energy X-ray radiography
Zeitfenster: A week prior to the study baseline
Whole-body dual-energy X-ray radiography scan
A week prior to the study baseline
Novel Pedar
Zeitfenster: During two one-hour bouts of the exercise intervention
Mechanosensitive shoe inserts for measurement of ground reaction force
During two one-hour bouts of the exercise intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Michigan

Mitarbeiter

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Wisconsin, La Crosse

Ermittler

  • Hauptermittler: Katarina T Borer, Professor Emerita

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)

8. Oktober 2009

Primärer Abschluss (Tatsächlich)

5. Dezember 2012

Studienabschluss (Tatsächlich)

20. Dezember 2012

Studienanmeldedaten

Zuerst eingereicht

19. April 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. April 2019

Zuerst gepostet (Tatsächlich)

29. April 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. April 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. April 2019

Zuletzt verifiziert

1. April 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • HUM32227/ HUM32700
  • R15DK082800 (US NIH Stipendium/Vertrag)
  • M01RR024986 (Andere Zuschuss-/Finanzierungsnummer: Michigan Institute of Clinical and Health Research)

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 .

Klinische Studien zur Diabetes mellitus, Typ 2

Klinische Studien zur Behavior intervention of uphill exercise

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Benin

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren