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Comparing the effectiveness of following a lower carbohydrate diet to a standard diet in controlling blood sugar levels in individuals with diabetes

Effectiveness of low carbohydrate diet to standard diet in individuals with diabetes mellitus type 2 (LOW CARB DIET): A cluster randomized trial randomized trial

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062202
Enrollment
320
Registered
2024-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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: Advice to follow a low carbohydrate diet (130 g of carbohydrate/day) in addition to the standard diabetes treatment : Dietary advice —20-minute one-on-one visit offering advice on fol

Sponsors

Department of Health Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
— 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 Timepoint: Follow-up will be for a year at 3, 6, 9 and 12 months

Secondary

MeasureTime frame
—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 — Understand meal-related glycemic fluctuations based on real-time continuous glucose monitoring tool Timepoint: Follow-up will be for a year at baseline, 6, & 12 months.

Countries

India

Contacts

Public ContactDr Joshua Chadwick

ICMR-National Insitute of Epedimiology, Chennai

joshuachadwick89@gmail.com09176270955

Outcome results

None listed

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