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To study the role of 2 different diets in the management of type 2 diabetes

To study the role of high carbohydrate whole food plant-based diet as compared to the standard mixed diabetic diet in the management of type 2 diabetes mellitus in a tertiary care hospital ââ?¬â?? a randomized controlled trial. - DiD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/09/045618
Enrollment
94
Registered
2022-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Whole food plant based diet - high carbohydrate diet: the intervention is a whole food plant based which is high carbohydrate rich diet (i.e. Carbohydrate will be 70-75% of the total ca

Sponsors

Christian Medical college Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 iv. Able to comprehend their participation in this study and willing to give informed written consent v. Agree to come for follow up

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India

Contacts

Public ContactOC Abraham

Christian Medical College Vellore

ocabraham@cmcvellore.ac.in

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026