Health Condition 1: E11- Type 2 diabetes mellitus
Conditions
Interventions
Sponsors
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
| Measure | Time 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
| Measure | Time 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
ICMR-National Insitute of Epedimiology, Chennai