- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05380232
Physical Activity and Mortality in Type 2 Diabetes
Physical Activity and Mortality in Individuals With Type 2 Diabetes: Cross-country Comparison in UK Biobank and China Kadoorie Biobank
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
AIM To determine dose-response patterns between leisure-time physical activity and all-cause mortality in individuals with type 2 diabetes in the United Kingdom and China. A secondary aim is to study the association between domain-specific physical activity and all-cause mortality and fatal and non-fatal CVD.
Study design and setting The study is a nested cohort study based on the UK Biobank and China Kadoorie Biobank population-based prospective cohort studies. Both cohorts are designed to study the interrelations between environment, lifestyle, and genes, with the aims of improving the prevention, diagnosis, and treatment of chronic diseases. UK Biobank recruited a total of 502,682 participants (approximately 5.5% of 9.2 million invited) aged 37 to 82 years via 22 assessment centers across England, Wales, and Scotland between 2006 and 2010. At the assessment centers participants completed a touch-screen questionnaire, an interview with a nurse, and a wide variety of physical measurements and biological sampling. A subsample has attended a repeat assessment of all data collected at the baseline examination. Data has been linked with several electronic registries for ongoing follow-up on health status. Ethical approval to establish the UK Biobank cohort was obtained by the North-West Research Ethics Committee and participants gave written informed consent before data collection. China Kadoorie Biobank recruited 515,420 participants aged 30 to 79 years between 2004 and 2008 from 10 regions of mainland China. At the assessment centers participants completed an interviewer-administered questionnaire, physical measurements and provided blood spot tests and non-fasting blood samples. Data has been linked with several electronic registries for ongoing follow-up on health status. China Kadoorie Biobank was approved by the Ethics Committees at Oxford University, the China National Center for Disease Control and from institutional research boards at the local Centers for Disease Control in the 10 included regions.
Study population The Investigators identified individuals with prevalent type 2 diabetes in the UK Biobank from the baseline assessment (2006-2010) and the 1st repeat assessment (2012-2013), and in China Kadoorie Biobank from the baseline assessment (2004-2008).
UK Biobank: Prevalent type 2 diabetes is determined by the algorithm by Eastwood (PMID: 27631769) or from measured Hba1c ≥48 mmol/mol. The algorithm is based on combining information on self-reported diabetes, insulin use, age of diabetes onset, and ethnicity obtained from a questionnaire in addition to self-reported diabetes, self-reported use of medications (see SAP), and age at diabetes diagnosis obtained from an interview with a trained nurse. Both 'probable' and 'possible' type 2 diabetes from the algorithm are included as type 2 diabetes cases. Type I diabetes is removed from the sample by combining information on insulin use, time from diagnosis to initiation of insulin use, and age of diagnosis. These criteria identify 29,236 individuals with type 2 diabetes.
China Kadoorie Biobank: prevalent type 2 diabetes is based on self-reported current diabetes with a diagnosis age above 30 years, a random plasma blood glucose ≥11.1 mmol/L, or fasting plasma blood glucose ≥7.0 mmol/L. These criteria identify 30,300 individuals with type 2 diabetes.
For further detail, please see attached predefined statistical analysis plan (SAP).
Typ studie
Zápis (Aktuální)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- UK Biobank: Prevalent type 2 diabetes is determined by the algorithm by Eastwood (PMID: 27631769) or from measured Hba1c ≥48 mmol/mol.
- China Kadoorie Biobank: Self-reported current diabetes with a diagnosis age above 30 years, a random plasma blood glucose ≥11.1 mmol/L, or fasting plasma blood glucose ≥7.0 mmol/L
Exclusion Criteria:
- None
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Individuals with type 2 diabetes at the baseline examination
UK Biobank: Prevalent type 2 diabetes is determined by the algorithm of Eastwood et al. (6) or from measured Hba1c ≥48 mmol/mol. China Kadoorie Biobank: prevalent type 2 diabetes is based on self-reported current diabetes with a diagnosis age above 30 years, a random plasma blood glucose ≥11.1 mmol/L, or fasting plasma blood glucose ≥7.0 mmol/L. |
Self-reported leisure-time physical activity, categorized as; zero (reference), >0-7.49
MET-hrs/week, 7.5-14.9
MET-hrs/week, or ≥15 MET-hrs/week.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
All-cause mortality
Časové okno: Through longest available follow-up, up to 14.5 years (UK Biobank)
|
Mortality status optained from registries.
The longest available follow-up from baseline examination will be used.
Deaths during the first 3 years will be left-censored.
|
Through longest available follow-up, up to 14.5 years (UK Biobank)
|
|
All-cause mortality
Časové okno: Through longest available follow-up, up to 12.4 years (China Kadoorie Biobank)
|
Mortality status optained from registries.
The longest available follow-up from baseline examination will be used.
Deaths during the first 3 years will be left-censored.
|
Through longest available follow-up, up to 12.4 years (China Kadoorie Biobank)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cardiovascular mortality
Časové okno: Through longest available follow-up, up to 14.5 (UK Biobank) and 0.4 (China Kadoorie Biobank) years
|
Cardiovascular mortality status optained from registries (I00 to I-99).
The longest available follow-up from baseline examination will be used.
Deaths during the first 3 years will be left-censored.
|
Through longest available follow-up, up to 14.5 (UK Biobank) and 0.4 (China Kadoorie Biobank) years
|
|
Major adverse cardiovascular events (MACE)
Časové okno: Through longest available follow-up, up to 14.5 (UK Biobank only)
|
MACE status optained from registries (I20-I25, I60, I61, I63, or I64 in addition to cardiovascular mortality).
The longest available follow-up from baseline examination will be used.
Participants with events during the first 3 years will be left-censored.
|
Through longest available follow-up, up to 14.5 (UK Biobank only)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 29717
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Diabetes mellitus, typ 2
-
Korea United Pharm. Inc.Zatím nenabíráme
-
Helen Keller Eye Research FoundationFive Lakes Clinical Research Consulting, LLCNáborSticklerův syndrom typu 2 | Sticklerův syndrom typu 1Spojené státy
-
Izmir Bakircay UniversityDokončenoDiabetes mellitus, typ 2 | Diabetes Mellitus, typ 2 léčený inzulínemTurecko (Türkiye)
-
Griffin HospitalCalifornia Walnut CommissionDokončenoDIABETES MELLITUS TYP 2Spojené státy
-
Services Hospital, LahoreDokončeno
-
Zhejiang Provincial People's HospitalShandong Suncadia Medicine Co., Ltd.Nábor
-
Universite du Quebec en OutaouaisUniversity Hospital, Angers; McGill University; Centre de Recherche du Centre...Zatím nenabírámeDiabetes mellitus, typ 1 | Diabetes, autoimunita | Diabetes typu 2 | Diabetes; Nástup v dospělostiKanada
-
Embecta Corp.Jaeb Center for Health ResearchStaženoCukrovka typu 2 | Diabetes mellitus 2. typu (T2DM) | T2DM (diabetes mellitus 2. typu) | T2D | T2DM | Typ 2 DM | T2DM s nedostatečnou kontrolou glykémieSpojené státy
-
Fujifilm Medical Systems USA, Inc.International HealthCare, LLCZatím nenabírámeRutinní screeningová mamografie
-
University of Roma La SapienzaNeznámýDiabetes Mellitus Typ 2 Reaktivita krevních destiček StatinItálie