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Effects of a Recreational Team Handball-based Programme on Health and Physical Fitness of Postmenopausal Women (H4HW)

28 marzo 2022 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Porto
      • Maia, Porto, Portogallo, 4476-690
        • University of Maia

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
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.
Nessun intervento: Control group
The control group participants were instructed to keep their regular daily physical activity for 36 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Between group differences in peak oxygen uptake at week 16
Lasso di tempo: Week 16
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Week 16
Between group differences in peak oxygen uptake at week 36
Lasso di tempo: Week 36
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Week 36
Changes from baseline in peak oxygen uptake at week 16
Lasso di tempo: Baseline and week 16
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Baseline and week 16
Changes from baseline in peak oxygen uptake at week 36
Lasso di tempo: Baseline and week 36
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Baseline and week 36
Changes from week 16 in peak oxygen uptake at week 36
Lasso di tempo: Week 16 and week 36
Determined by pulmonary gas exchange measurements, during an incremental treadmill test until voluntary exhaustion.
Week 16 and week 36

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Between group differences in resting heart rate at week 16
Lasso di tempo: Week 16
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Week 16
Between group differences in resting heart rate at week 36
Lasso di tempo: Week 36
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Week 36
Changes from baseline in resting heart rate at week 16
Lasso di tempo: Baseline and week 16
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Baseline and week 16
Changes from baseline in resting heart rate at week 36
Lasso di tempo: Baseline and week 36
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Baseline and week 36
Changes from week 16 in resting heart rate at week 36
Lasso di tempo: Week 16 and week 36
Determined by an automatic upper arm blood pressure monitor according to standardized procedures.
Week 16 and week 36
Between group differences in body mass at week 16
Lasso di tempo: Week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 16
Between group differences in body mass at week 36
Lasso di tempo: Week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 36
Changes from baseline in body mass at week 16
Lasso di tempo: Baseline and week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Baseline and week 16
Changes from baseline in body mass at week 36
Lasso di tempo: Baseline and week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Baseline and week 36
Changes from week 16 in body mass at week 36
Lasso di tempo: Week 16 and week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 16 and week 36
Between group differences in fat mass at week 16
Lasso di tempo: Week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 16
Between group differences in fat mass at week 36
Lasso di tempo: Week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 36
Changes from baseline in fat mass at week 16
Lasso di tempo: Baseline and week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Baseline and week 16
Changes from baseline in fat mass at week 36
Lasso di tempo: Baseline and week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Baseline and week 36
Changes from week 16 in fat mass at week 36
Lasso di tempo: Week 16 and week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 16 and week 36
Between group differences in lean mass at week 16
Lasso di tempo: Week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 16
Between group differences in lean mass at week 36
Lasso di tempo: Week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 36
Changes from baseline in lean mass at week 16
Lasso di tempo: Baseline and week 16
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Baseline and week 16
Changes from baseline in lean mass at week 36
Lasso di tempo: Baseline and week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Baseline and week 36
Changes from week 16 in lean mass at week 36
Lasso di tempo: Week 16 and week 36
Determined by whole-body dual- energy X-ray absorptiometry following standard procedures.
Week 16 and week 36
Between group differences in lumbar spine bone mineral density at week 16
Lasso di tempo: Week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16
Between group differences in lumbar spine bone mineral density at week 36
Lasso di tempo: Week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 36
Changes from baseline in lumbar spine bone mineral density at week 16
Lasso di tempo: Baseline and week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Baseline and week 16
Changes from baseline in lumbar spine bone mineral density at week 36
Lasso di tempo: 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 lumbar spine bone mineral density at week 36
Lasso di tempo: Week 16 and week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16 and week 36
Between group differences in dominant femur bone mineral density at week 16
Lasso di tempo: Week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16
Between group differences in dominant femur bone mineral density at week 36
Lasso di tempo: 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
Lasso di tempo: Baseline and week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Baseline and week 16
Changes from baseline in dominant femur bone mineral density at week 36
Lasso di tempo: 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
Lasso di tempo: Week 16 and week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16 and week 36
Between group differences in dominant femoral neck bone mineral density at week 16
Lasso di tempo: Week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16
Between group differences in dominant femoral neck bone mineral density at week 36
Lasso di tempo: Week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 36
Changes from baseline in dominant femoral neck bone mineral density at week 16
Lasso di tempo: Baseline and week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Baseline and week 16
Changes from baseline in dominant femoral neck bone mineral density at week 36
Lasso di tempo: 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 density at week 36
Lasso di tempo: Week 16 and week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16 and week 36
Between group differences in lumbar spine bone mineral content at week 16
Lasso di tempo: Week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16
Between group differences in lumbar spine bone mineral content at week 36
Lasso di tempo: Week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 36
Changes from baseline in lumbar spine bone mineral content at week 16
Lasso di tempo: Baseline and week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Baseline and week 16
Changes from baseline in lumbar spine bone mineral content at week 36
Lasso di tempo: 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 lumbar spine bone mineral content at week 36
Lasso di tempo: Week 16 and week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16 and week 36
Between group differences in dominant femur bone mineral content at week 16
Lasso di tempo: Week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16
Between group differences in dominant femur bone mineral content at week 36
Lasso di tempo: Week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 36
Changes from baseline in dominant femur bone mineral content at week 16
Lasso di tempo: Baseline and week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Baseline and week 16
Changes from baseline in dominant femur bone mineral content at week 36
Lasso di tempo: 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 content at week 36
Lasso di tempo: Week 16 and week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16 and week 36
Between group differences in dominant femoral neck bone mineral content at week 16
Lasso di tempo: Week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16
Between group differences in dominant femoral neck bone mineral content at week 36
Lasso di tempo: Week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 36
Changes from baseline in dominant femoral neck bone mineral content at week 16
Lasso di tempo: Baseline and week 16
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Baseline and week 16
Changes from baseline in dominant femoral neck bone mineral content at week 36
Lasso di tempo: 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
Lasso di tempo: Week 16 and week 36
Determined by dual- energy X-ray absorptiometry regional scans following standard procedures.
Week 16 and week 36
Between group differences in osteocalcin at week 16
Lasso di tempo: Week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16
Between group differences in osteocalcin at week 36
Lasso di tempo: Week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 36
Changes from baseline in osteocalcin at week 16
Lasso di tempo: Baseline and week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Baseline and week 16
Changes from baseline in osteocalcin at week 36
Lasso di tempo: Baseline and week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Baseline and week 36
Changes from week 16 in osteocalcin at week 36
Lasso di tempo: Week 16 and week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16 and week 36
Between group differences in procollagen type-1 amino-terminal propeptide at week 16
Lasso di tempo: Week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16
Between group differences in procollagen type-1 amino-terminal propeptide at week 36
Lasso di tempo: 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
Lasso di tempo: Baseline and week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Baseline and week 16
Changes from baseline in procollagen type-1 amino-terminal propeptide at week 36
Lasso di tempo: Baseline and week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Baseline and week 36
Changes from week 16 in procollagen type-1 amino-terminal propeptide at week 36
Lasso di tempo: Week 16 and week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16 and week 36
Between group differences in carboxy-terminal type-1 collagen crosslinks at week 16
Lasso di tempo: Week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16
Between group differences in carboxy-terminal type-1 collagen crosslinks at week 36
Lasso di tempo: Week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 36
Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 16
Lasso di tempo: Baseline and week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Baseline and week 16
Changes from baseline in carboxy-terminal type-1 collagen crosslinks at week 36
Lasso di tempo: 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
Lasso di tempo: Week 16 and week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16 and week 36
Between group differences in sclerostin at week 16
Lasso di tempo: Week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16
Between group differences in sclerostin at week 36
Lasso di tempo: Week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 36
Changes from baseline in sclerostin at week 16
Lasso di tempo: Baseline and week 16
Determined by chemiluminescence method using a fully automated immunoassay system.
Baseline and week 16
Changes from baseline in sclerostin at week 36
Lasso di tempo: Baseline and week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Baseline and week 36
Changes from week 16 in sclerostin at week 36
Lasso di tempo: Week 16 and week 36
Determined by chemiluminescence method using a fully automated immunoassay system.
Week 16 and week 36
Between group differences in isometric knee extension peak torque at week 16
Lasso di tempo: Week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Week 16
Between group differences in isometric knee extension peak torque at week 36
Lasso di tempo: Week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Week 36
Changes from baseline in isometric knee extension peak torque at week 16
Lasso di tempo: Baseline and week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Baseline and week 16
Changes from baseline in isometric knee extension peak torque at week 36
Lasso di tempo: Baseline and week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Baseline and week 36
Changes from week 16 in isometric knee extension peak torque at week 36
Lasso di tempo: Week 16 and week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Week 16 and week 36
Between group differences in isometric knee extension rate of force development at week 16
Lasso di tempo: Week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Week 16
Between group differences in isometric knee extension rate of force development at week 36
Lasso di tempo: Week 36
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
Lasso di tempo: Baseline and week 16
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Baseline and week 16
Changes from baseline in isometric knee extension rate of force development at week 36
Lasso di tempo: Baseline and week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Baseline and week 36
Changes from week 16 in isometric knee extension rate of force development at week 36
Lasso di tempo: Week 16 and week 36
Determined by a Biodex isokinetic dynamometer, during a isometric knee extension contraction
Week 16 and week 36
Between group differences in upper body strength at week 16
Lasso di tempo: Week 16
Determined by a handgrip dynamometer.
Week 16
Between group differences in upper body strength at week 36
Lasso di tempo: Week 36
Determined by a handgrip dynamometer.
Week 36
Changes from baseline in upper body strength at week 16
Lasso di tempo: Baseline and week 16
Determined by a handgrip dynamometer.
Baseline and week 16
Changes from baseline in upper body strength at week 36
Lasso di tempo: Baseline and week 36
Determined by a handgrip dynamometer.
Baseline and week 36
Changes from week 16 in upper body strength at week 36
Lasso di tempo: Week 16 and week 36
Determined by a handgrip dynamometer.
Week 16 and week 36
Between group differences in postural balance at week 16
Lasso di tempo: Week 16
Determined by the number of falls in a single-legged flamingo balance test.
Week 16
Between group differences in postural balance at week 36
Lasso di tempo: Week 36
Determined by the number of falls in a single-legged flamingo balance test.
Week 36
Changes from baseline in postural balance at week 16
Lasso di tempo: Baseline and week 16
Determined by the number of falls in a single-legged flamingo balance test.
Baseline and week 16
Changes from baseline in postural balance at week 36
Lasso di tempo: Baseline and week 36
Determined by the number of falls in a single-legged flamingo balance test.
Baseline and week 36
Changes from week 16 in postural balance at week 36
Lasso di tempo: Week 16 and week 36
Determined by the number of falls in a single-legged flamingo balance test.
Week 16 and week 36
Between group differences in aerobic performance at week 16
Lasso di tempo: Week 16
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Week 16
Between group differences in aerobic performance at week 36
Lasso di tempo: Week 36
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Week 36
Changes from baseline in aerobic performance at week 16
Lasso di tempo: Baseline and week 16
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Baseline and week 16
Changes from baseline in aerobic performance at week 36
Lasso di tempo: Baseline and week 36
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Baseline and week 36
Changes from week 16 in aerobic performance at week 36
Lasso di tempo: Week 16 and week 36
Determined by meters covered in the Yo-Yo intermittent endurance level 1 test.
Week 16 and week 36
Between group differences in total cholesterol at week 16
Lasso di tempo: Week 16
Determined by an automated analyser.
Week 16
Between group differences in total cholesterol at week 36
Lasso di tempo: Week 36
Determined by an automated analyser.
Week 36
Changes from baseline in total cholesterol at week 16
Lasso di tempo: Baseline and week 16
Determined by an automated analyser.
Baseline and week 16
Changes from baseline in total cholesterol at week 36
Lasso di tempo: Baseline and week 36
Determined by an automated analyser.
Baseline and week 36
Changes from week 16 in total cholesterol at week 36
Lasso di tempo: Week 16 and week 36
Determined by an automated analyser.
Week 16 and week 36
Between group differences in high-density lipoprotein cholesterol at week 16
Lasso di tempo: Week 16
Determined by an automated analyser.
Week 16
Between group differences in high-density lipoprotein cholesterol at week 36
Lasso di tempo: Week 36
Determined by an automated analyser.
Week 36
Changes from baseline in high-density lipoprotein cholesterol at week 16
Lasso di tempo: Baseline and week 16
Determined by an automated analyser.
Baseline and week 16
Changes from baseline in high-density lipoprotein cholesterol at week 36
Lasso di tempo: Baseline and week 36
Determined by an automated analyser.
Baseline and week 36
Changes from week 16 in high-density lipoprotein cholesterol at week 36
Lasso di tempo: Week 16 and week 36
Determined by an automated analyser.
Week 16 and week 36
Between group differences in low-density lipoprotein cholesterol at week 16
Lasso di tempo: Week 16
Determined by an automated analyser.
Week 16
Between group differences in low-density lipoprotein cholesterol at week 36
Lasso di tempo: Week 36
Determined by an automated analyser.
Week 36
Changes from baseline in low-density lipoprotein cholesterol at week 16
Lasso di tempo: Baseline and week 16
Determined by an automated analyser.
Baseline and week 16
Changes from baseline in low-density lipoprotein cholesterol at week 36
Lasso di tempo: Baseline and week 36
Determined by an automated analyser.
Baseline and week 36
Changes from week 16 in low-density lipoprotein cholesterol at week 36
Lasso di tempo: Week 16 and week 36
Determined by an automated analyser.
Week 16 and week 36
Between group differences in triglycerides at week 16
Lasso di tempo: Week 16
Determined by an automated analyser.
Week 16
Between group differences in triglycerides at week 36
Lasso di tempo: Week 36
Determined by an automated analyser.
Week 36
Changes from baseline in triglycerides at week 16
Lasso di tempo: Baseline and week 16
Determined by an automated analyser.
Baseline and week 16
Changes from baseline in triglycerides at week 36
Lasso di tempo: Baseline and week 36
Determined by an automated analyser.
Baseline and week 36
Changes from week 16 in triglycerides at week 36
Lasso di tempo: Week 16 and week 36
Determined by an automated analyser.
Week 16 and week 36
Between group differences in fasting glucose at week 16
Lasso di tempo: Week 16
Determined by an automated analyser.
Week 16
Between group differences in fasting glucose at week 36
Lasso di tempo: Week 36
Determined by an automated analyser.
Week 36
Changes from baseline in fasting glucose at week 16
Lasso di tempo: Baseline and week 16
Determined by an automated analyser.
Baseline and week 16
Changes from baseline in fasting glucose at week 36
Lasso di tempo: Baseline and week 36
Determined by an automated analyser.
Baseline and week 36
Changes from week 16 in fasting glucose at week 36
Lasso di tempo: Week 16 and week 36
Determined by an automated analyser.
Week 16 and week 36
Between group differences in fasting insulin at week 16
Lasso di tempo: Week 16
Determined by an automated analyser.
Week 16
Between group differences in fasting insulin at week 36
Lasso di tempo: Week 36
Determined by an automated analyser.
Week 36
Change from baseline in fasting insulin at week 16
Lasso di tempo: Baseline and week 16
Determined by an automated analyser.
Baseline and week 16
Change from baseline in fasting insulin at week 36
Lasso di tempo: Baseline and week 36
Determined by an automated analyser.
Baseline and week 36
Change from week 16 in fasting insulin at week 36
Lasso di tempo: Week 16 and week 36
Determined by an automated analyser.
Week 16 and week 36
Between group differences in glucose tolerance at week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Week 16 and week 36
Determined by an oral glucose tolerance teste, analysed by an automated analyser.
Week 16 and week 36

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 gennaio 2016

Completamento primario (Effettivo)

1 marzo 2018

Completamento dello studio (Effettivo)

1 marzo 2018

Date di iscrizione allo studio

Primo inviato

14 marzo 2022

Primo inviato che soddisfa i criteri di controllo qualità

14 marzo 2022

Primo Inserito (Effettivo)

23 marzo 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 aprile 2022

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 marzo 2022

Ultimo verificato

1 marzo 2022

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CEFADE202019

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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