Diabetes Nutritional, Metabolic, Endocrine Non-insulin dependant diabetes mellitus
Conditions
Interventions
This is a two-phase pragmatic single centre, community based, un-blinded randomised controlled feasibility trial. It will compare two 'diet, exercise and motivation' programs with each other and with
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantitative data: Biochemical parameters will be measured at baseline, at the end of the 12 month trial and at predetermined times in between. The biochemical variables to be measured are fasting blood sugar, fasting blood insulin, fasting insulin/glucose ratio and fasting lipid profile. Samples will be collected at baseline and at four, twelve, twenty-four weeks and at seven, nine and twelve months. Biophysical parameters will be measured at baseline, at the end of the 12 month trial and at predetermined times in between. The biophysical parameters are weight, height, body mass index (BMI), waist and hip circumference, hip/waist circumference ratio and body fat percentage measured by electrical impedance. Qualitative data: Subjective comment and observation will be solicited from both the trial staff and the trial subjects. This will be presented in a narrative fashion. Narrative data will be collected from a questionnaire. The questionnaire is in preparation presently. Narrative data is being collected principally to inform the ISAIAH team about the subject's experiences of being on the programme with a view to refining the protocol of the anticipated subsequent large cluster randomised trial. Questionnaires will be collected, but not looked at, by the evening meeting team. They will be regarded as confidential and will be forwarded to Dr Barclay assessment and for analysis at the end of the trial. The qualitative data will address several areas of interest: 1. The conduct, content and arrangements of the evening meeting programme 2. The educational content of the programme 3. Experience with measures of 'adherence' (diet and exercise diaries) 4. Controls experience of waiting to begin the programme 5. 'Other' comments: Every questionnaire will have a section left available for observations and comments by the subjects. These will be collected and surveyed to inform the team as part of the planning for the next trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
United Kingdom
Outcome results
None listed