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Physical Activity and Mortality in Type 2 Diabetes

15 mai 2022 mis à jour par: Jakob Tarp, Aarhus University Hospital

Physical Activity and Mortality in Individuals With Type 2 Diabetes: Cross-country Comparison in UK Biobank and China Kadoorie Biobank

The primary aim of study is to study the association between leisure-time physical activity and all-cause mortality among individuals with type 2 diabetes in the UK Biobank cohort and the China Kadoorie Biobank cohort. Secondary outcomes are CVD-mortality (both cohorts) and risk of major adverse cardiovascular events (UK Biobank only). Secondary exposures are physical activity from transportation and occupation.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Réel)

502682

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans à 80 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

See statistical analysis plan

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
All-cause mortality
Délai: 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
Délai: 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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cardiovascular mortality
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 mars 2006

Achèvement primaire (Réel)

1 octobre 2021

Achèvement de l'étude (Réel)

30 octobre 2021

Dates d'inscription aux études

Première soumission

5 mai 2022

Première soumission répondant aux critères de contrôle qualité

15 mai 2022

Première publication (Réel)

18 mai 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 mai 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mai 2022

Dernière vérification

1 mai 2022

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 29717

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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