A pilot study to look at the efficacy of a dietitian-led intervention using a homemade Very Low Calorie Diet (VLCD) to achieve prevention or remission of type 2 diabetes.
Not Applicable
Completed
- Conditions
- Prevention or reversal of type 2 diabetes in participants with pre-diabetes or type 2 diabetes diagnosed within the previous 4 years.Nutritional, Metabolic, EndocrineType 2 diabetes mellitus
- Registration Number
- ISRCTN15555357
- Lead Sponsor
- niversity of the Highlands and Islands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
Inclusion Criteria
1. Informed written consent
2. Men and women with prediabetes (HbA1c 42 - 47 mmol/mol)
3. Men and women with Type 2 Diabetes, on diet, monotherapy or dual therapy within 4 years of diagnosis and not taking insulin
4. BMI >35kg/m²
5. Age 20 - 70years
Exclusion Criteria
1. BMI < 35 kg/m²
2. HbA1c >100mmol/mol
3. Insulin use
4. Pregnant or planning pregnancy
5. Diagnosed eating disorder
6. Renal function eGFR <30ml/min
7. Myocardial Infarction (MI) withing previous 6 months
8. Severe heart failure
9. Taking part in another research study
10. Cancer
11. Liver disease but not excluding Non Alcoholic Fatty Livr Disease (NAFLD)
12. Severe depression and those on antipsychotic medication
13. History of substance misuse
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. HbA1c is measured by Raigmore Hospital Biochemistry department at baseline, and 12, 24, 36, and 48 weeks.<br>2. Weight (kg) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic scales.<br>3. Waist circumference (cm) is measured at baseline, 12, 24, 36, and 48 weeks by NHS research nurse team staff using standard Diabetes clinic measuring tape. <br>4. BMI (kg/m²) is calculated, by research staff using height taken at baseline and weight at baseline 12, 24, 36, and 48 weeks.
- Secondary Outcome Measures
Name Time Method 1. Redoxiperoxin and Glutathione is analysed by UHI Division of Biomedical Sciences by way of a novel ALISA technique, Antibody linked Oxi-State Assay and/or HPLC-ECD. All samples will be stored on arrival in the UHI labs and batch analysed at the end of the collection period.<br>2. Diet Acceptability is measured by way of questionnaire at 4 weeks.<br>3. Self regulation of eating is measured at baseline, 12, 24, 36, and 48 weeks by way of Self Regulation of Eating Behaviour questionnaire (SREBQ)<br>4. Quality of life is measured at baseline, 12, 24, 36, and 48 weeks by way of Health Questionnaire EQ-5D-5