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Prevention of diabetes in South Asians with impaired glucose levels: a family based clinical trial using physical activity and dietary modification

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25729565
Enrollment
170
Registered
2007-01-30
Start date
2006-08-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Nutritional, Metabolic and Endocrine Diseases: type 2 Diabetes Nutritional, Metabolic, Endocrine Diabetes

Interventions

Intervention group will receive 15 contacts with trained dieticians over 3 years with the goal of reducing weight and increasing physical activity. Control group will receive 4 contacts over 3 years t

Sponsors

The Queen?s Medical Research Institute (United Kingdom)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Self-assigned ethnic group using Census 2001 categories as Indian or Pakistani 2. Normal place of residence is in Greater Glasgow & Clyde or Lothian Health board areas 3. Given informed consent 4. Impaired glucose tolerance (IGT) on oral glucose tolerance test (OGTT) at least once 5. An age of 35 or more 6. A waist size of > 90 cm (men) or > 80 cm (women) 7. No confirmed medical history of diabetes (other than gestational diabetes)

Exclusion criteria

Exclusion criteria: 1. The main cook for the potential participant with IGT is unwilling to give consent to cooperate 2. A diagnosis of diabetes made on the OGTT during the screening phase of the study 3. Other disease where adherence to the intervention is contraindicated or improbable e.g. terminal illness or psychological or physical illnesses; alcohol dependency; planned or actual pregnancy; use of prescribed drugs that affect the primary outcome 4. An expectation, reported by participants or the GP, that the person will be emigrating or dying before the conclusion of the trial 5. Failure to make a commitment to stay in the study until, at least, the three year follow-up examination

Design outcomes

Primary

MeasureTime frame
Current information as of 26/04/10: Weight change at 3 years. Initial information at time of registration: To evaluate whether a 3-year family based programme combining weight loss and physical activity can reduce the incidence of type 2 diabetes in South Asians with impaired glucose tolerance.

Secondary

MeasureTime frame
Added 26/04/10: 1. Changes in fasting and 2-hour glucose 2. Progression to type 2 diabetes 3. Body Mass Index (BMI) 4. Waist circumference and hip circumference 5. Cost effectiveness

Countries

United Kingdom

Outcome results

None listed

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