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

Not Applicable

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Non-insulin dependent diabetes mellitus

• Registration Number: ISRCTN92162869
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2011 Results article in http://www.ncbi.nlm.nih.gov/pubmed/21705068 2014 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/24811615 Effect on inflammatory markers 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29386030 Qualitative analysis of motivation 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35430794/ Analysis of association of glycaemic control with diet independent of weight change (added 19/04/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-25
• Study Completion: 2008-07-31
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 593

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control as measured by HbA1c and systolic and diastolic blood pressure, at 6 months.

Secondary Outcome Measures

Name	Time	Method
ipids, insulin resistance, weight/body composition, and amount of medication required to control diabetes and blood pressure at 12 months.