- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
All-cause mortality
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cardiovascular mortality
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 29717
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .
Prove cliniche su Leisure-time physical activity
-
Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)CompletatoAttività fisica | Morbo di Parkinson | Bilancia | Cadente | KinesiofobiaTacchino
-
University of BariProf. Maria GranoCompletato
-
Universiteit AntwerpenUniversity Hospital, Antwerp; Cliniques universitaires Saint-Luc- Université...CompletatoEmofilia A | Emofilia BBelgio