To study the role of 2 different diets in the management of type 2 diabetes
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2022/09/045618
- Lead Sponsor
- Christian Medical college Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
i.Type 2 diabetes mellitus on life style intervention +/- on oral hyperglycemic agents.
ii. Not using insulin at present.
iii. HBA1c at OPD visit should be > 7 g% and <8.5 g%
iv. Able to comprehend their participation in this study and willing to give informed written consent
v. Agree to come for follow up
i.Diabetic patients who are pure vegans
ii.History of diabetic ketoacidosis or hyperglycemic hyperosmolar state.
iii.History of malabsorptive conditions - > Coeliac disease, IBD
iv.History of lactose deficiency
v.Any malnutrition disorders
vi.Any previously diagnosed positive for antibodies which is suggestive of another variant of diabetes mellitus
vii.History of diabetic macrovascular complications - coronary artery disease, cerebrovascular accident, peripheral arterial occlusive disease.
viii.Evidence of chronic kidney disease (creatinine clearance less than 60 ml/min/m2)
ix.Low socio-economic status, where-in diets may not be feasible.
x.When both the patient and the immediate family members are both illiterate, which includes inability to read or comprehend the diet details from the brochure and not able to attend a mobile call.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effect of the high carbohydrate whole food plant-based diet and a standard diabetic diet on the glycated hemoglobin in type 2 diabetics.Timepoint: After 3 months
- Secondary Outcome Measures
Name Time Method Diet satisfaction questionnaireTimepoint: After 3 months;I.Assess the change in body composition profile and anthropometric parametersTimepoint: After 3 months;II.Fasting lipid profileTimepoint: After 3 months;III. Blood pressureTimepoint: After 3 months;IV.Fasting and 2 hr post prandial glucose levelsTimepoint: After 3 months;V.To assess for change in cognition score based on the Montreal cognitive assessment questionnaire.Timepoint: After 3 months