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A randomised controlled trial of the benefits of exercise early in the management of Type 2 diabetes

A randomised controlled trial of the benefits of exercise early in the management of Type 2 diabetes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN92162869
Enrollment
750
Registered
2005-07-25
Start date
2005-07-01
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin dependent diabetes mellitus

Interventions

1. Intensive dietary intervention 2. Increased exercise and intensive dietary intervention 3. Control: Usual Care Individuals recruited into all 3 arms

Sponsors

University of Bristol (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: This a multicentre trial recruiting 750 participants from across the South West of England. Individuals must satisfy the following criteria before they can be considered eligible: 1. Type 2 diabetes mellitus (T2DM) as defined by: body mass index (BMI) >25, no ketosis, no significant weight loss prior to diagnosis, aged above 30 at diagnosis 2. Between 5 and 8 months from clinical diagnosis of T2DM

Exclusion criteria

Exclusion criteria: 1. Age over 80 at diagnosis 2. HbA1c of greater than 10% 3. Blood pressure greater than 180/100 4. Low-density lipoprotein (LDL) greater than 4 5. Patients already receiving a maximum dose of a sulphonylurea 6. Have a current diagnosis of unstable angina 7. Have had a myocardial infarction within the previous three months 8. Unable to increase their physical activity 9. Subject is pregnant or is of childbearing age and not surgically sterile, 2 years postmenopausal or does not practice one method of contraception

Design outcomes

Primary

MeasureTime frame
Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months.

Secondary

MeasureTime frame
Lipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026