Limiting Meal Frequency (3 Larger Meals a Day) or Meal Size (Diabetic Plate) — Which is Effective in the Management of Type 2 Diabetes Mellitus? A Pragmatic Clinical Trial
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Recruiting
- Sponsor
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Difference in
Study Overview
Brief Summary
Background: One out of 11 Indians formally diagnosed with diabetes, makes India second most affected in the world. Restricted diet pattern has the greatest impact on the management of DM, but these are complex and difficult to comply.
Novelty: There is an unmet need to evolve dietary strategies from pragmatic trials. A simplified approach that can be easily understandable as well as implemented at low literacy and resource constraint settings is imperative for management of T2DM.
Objective: To compare the effectiveness of interventions: restricted meal frequency and meal size in uncomplicated diabetic patients attending the urban NCD clinic of AIIMS Kalyani.
Methods: Two-arm parallel Open-label controlled pragmatic trial with 1:1 allocation ratio using permutated block randomization technique.
Expected outcomes: Change in biomarkers of glucose metabolism (i.e., fasting and 2-hour postprandial glucose and hemoglobin A1c), lipid profile, weight, waist-hip ratio, and perceived treatment satisfaction and efficacy levels.
Applicability: These study findings aid in the effective management and reversal of T2DM. These interventions shall be incorporated into the policies at the national level to reduce the burden of primary health care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Currently diabetic, as defined by HbA1c ≥6.5gm% and/or current antidiabetic medication.
- •Diabetic duration: less than or equal to 12 months.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Difference in
Time Frame: baseline and end of 3 months.
1. HbA1c
Time Frame: baseline and end of 3 months.
2. fasting and post prandi9al glucose
Time Frame: baseline and end of 3 months.
3. fasting insulin
Time Frame: baseline and end of 3 months.
Secondary Outcomes
- Difference in(1. fasting lipid profile,)
Investigators
Sembagamuthu Sembiah
All India Institute of Medical Sciences Kalyani