AzTrials
AzTrials

Diabetes Mellitus, Type 2NCT05380232

Physical Activity and Mortality in Type 2 Diabetes

An observational study of Diabetes Mellitus, Type 2, run by Aarhus University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Leisure-time physical activity
How many people
502,682 participants
Where
No sites listed yet
Study dates
Mar 2006to 30 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: See statistical analysis plan

Who may be able to join

  • 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

Who cannot join

  • None

About this study

Official title: 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.

Read the detailed description

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).

Being tested
Leisure-time physical activity
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leisure-time physical activityBehavioural

    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.

Study groups in NCT05380232
Study groupRoleWhat they receive
Individuals with type 2 diabetes at the baseline examinationUK 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.
Receives: Behavioral: Leisure-time physical activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through longest available follow-up, up to 14.5 years (UK Biobank)

  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.

    Measured: Through longest available follow-up, up to 12.4 years (China Kadoorie Biobank)

Secondary outcomes (2)
  1. Cardiovascular mortality

    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.

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

  2. Major adverse cardiovascular events (MACE)

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study startMar 2006
  3. Primary completionOct 2021
  4. Study completion30 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
502,682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05380232
Sponsor's protocol ID
29717
Status last verified
May 2022
First submitted
5 May 2022
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 2, run by Aarhus University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: Through longest available follow-up, up to 14.5 years (UK Biobank)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in