Comparing the effectiveness of following a lower carbohydrate diet to a standard diet in controlling blood sugar levels in individuals with diabetes
Phase 2
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2024/02/062202
- Lead Sponsor
- Department of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
— Men and women over the age of 30 who have type 2 diabetes with or without comorbid conditions and a HbA1c level of =6.5% during the screening test
— Agree to participate with written consent
Exclusion Criteria
Terminal illness
Mental illness
Learning difficulties
Diagnosed eating disorder or purging
Pregnant/ considering pregnancy in the next 12 months
Current use of weight-loss drugs or use of oral glucocorticoids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method — Improved glycaemic control in adapting a lower carbohydrate diet in addition to standard of care for patients with T2DM when compared to those patients who followed the standard diet and treatment at one year follow up <br/ ><br>Timepoint: Follow-up will be for a year at 3, 6, 9 and 12 months
- Secondary Outcome Measures
Name Time Method —Improved cardio-renal risk variables such as body weight, lipid profile, serum creatinine, blood pressure (BP), HOMA IR, effect on diabetes medication prescription & any adverse events <br/ ><br>— Understand meal-related glycemic fluctuations based on real-time continuous glucose monitoring tool <br/ ><br>Timepoint: Follow-up will be for a year at baseline, 6, & 12 months.