A community based randomised controlled trial of a low calorie/low fat diet with a low glycaemic load diet in pre-diabetes mellitus: a feasibility study (The ISAIAH Project)

Completed

• Conditions: Diabetes; Nutritional, Metabolic, Endocrine; Non-insulin dependant diabetes mellitus

• Registration Number: ISRCTN22865846
• Lead Sponsor: Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Forty consecutive patients identified with pre-diabetes at 'The Nethergreen Surgery', Sheffield, will be given verbal and written information about the proposed study by the NHS practice nurse or GP who initially gives the diagnosis of pre-diabetes to the patient.

Those who consent and enrol into the study will be randomised to one of two groups, the study group and the control group. These two groups will be further randomised to one diet of the other. The Study groups will commence their programme at week one. The Controls will wait to enter the programme until week 26 when they cease to be controls for the study group and become a study group themselves. The whole study finishes after 52 weeks

Power calculations have not been performed for this study as it is a feasibility project. It is anticipated that the results of this study will be used to calculate power for a larger subsequent study.

Exclusion Criteria

1. Participants known to be related or living under the same roof of a subject already recruited; the first subject seen and consented will be allowed to proceed with the trial. Second and subsequent subjects will be ineligible to avoid being randomised to the contrary group and contaminating the trial protocol.
2. Use of medication: patients on oral costicosteroids, oral or injected contraceptives, oral or transdermal hormone replacement therapy (HRT) products or other medications that may interfere with gastrointestinal function, glucose/insulin or lipid metabolism
3. Alcohol and drug abuse: absolute exclusions
4. Medical conditions: conditions which can affect weight, fat or glucose metabolism. These include diabetes mellitus, unstable thyroid disease, malignancy disease, malabsorptive syndromes, known cholelithiasis, hepatic and renal disease.
5. Pregnancy and lactation: absolute exclusions
6. Psychiatric conditions: absolute exclusions

Study & Design

• Study Type: Interventional
• Study Design: Not specified