NCT05380232

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
502,682

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
15.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

15.6 years

First QC Date

May 5, 2022

Last Update Submit

May 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    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

    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)

Secondary Outcomes (2)

  • Cardiovascular mortality

    Through longest available follow-up, up to 14.5 (UK Biobank) and 0.4 (China Kadoorie Biobank) years

  • Major adverse cardiovascular events (MACE)

    Through longest available follow-up, up to 14.5 (UK Biobank only)

Study Arms (1)

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.

Behavioral: Leisure-time physical activity

Interventions

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.

Individuals with type 2 diabetes at the baseline examination

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See statistical analysis plan

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 18, 2022

Study Start

March 1, 2006

Primary Completion

October 1, 2021

Study Completion

October 30, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05