Effect Of 44-46% Carbohydrate (From Local And Traditional Sources) Diet with Regular Walk On Weight, Waist Circumference, Blood Pressure,Blood Glucose Levels, Blood lipid Levels

Effect Of Local Healthy Moderate Carbohydrate Diet With Defined Exercise On Metabolic Parameters In Patients with Type 2 Diabetes Mellitus - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056621

Enrollment

117

Registered

2023-08-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-10-14

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Local Healthy Moderate Carbohydrate Diet and Defined Exercise: Diet counselling and plan Calories- 20 calorie/kgIBW/day ,44-46 % carbohydrate, 25-30% proteins. 25-30 % fatsvegetarian an

Eligibility

Inclusion criteria

Inclusion criteria: Patients with type 2 diabetes of 2 years or less duration, managed with lifestyle modification or on oral antidiabetic therapy of 2 or less drugs (Metformin/DPP 4 inhibitors/SGLT 2 inhibitors/Sulphonylureas 2mg of glimepiride or equivalent dose) 2. Age- 18-75 years 3. BMI- 18-40 kg/m2 4.HbA1c between- 6.5% -9.0 %, fasting plasma glucose 5.Heamoglobin percentage between 8.5-16 gm/dL

Exclusion criteria

Exclusion criteria: 1. Patients with type 2 diabetes mellitus on insulin or on pioglitazone or more than two oral antidiabetic drugs 2. Pregnant women 3.Patients with type 1 diabetes mellitus (T1DM)/ Latent autoimmune diabetes of adult (LADA)/ Secondary or drug induced diabetes /Monogenic diabetes 4. Patients with severe retinopathy, macular edema, severe neuropathy, previous history cardiovascular or cerebrovascular complications or has undergone any intervention for the same. 4. Patients having decompensated or advanced liver or kidney disease (eGFR any other patients with acute illness or infection. 5.Patients with duration of diabetes more than 2 years. 6.Patients with hemoglobinopathies and Hb percentage 16% 7.Participants having fasting C peptide level 9.0%, Fasting blood glucose >200 mg/dL

Design outcomes

Primary

Measure	Time frame
1. Percentage of patients achieving normalisation of blood glucose levels with nutritional intervention consisting of healthy local sustainable diet. 2. Percentage of patients achieving remission of type 2 diabetes with nutritional intervention consisting of healthy local sustainable diet. 3. Phenotypic characteristics of the patients achieving normalisation of blood glucose levels at the end of intervention & of those patients achieving remission of diabetes at the end of one year. Timepoint: six months one year 18 months	—

Measure

Time frame

1. Percentage of patients achieving normalisation of blood glucose levels with nutritional intervention consisting of healthy local sustainable diet. 2. Percentage of patients achieving remission of type 2 diabetes with nutritional intervention consisting of healthy local sustainable diet. 3. Phenotypic characteristics of the patients achieving normalisation of blood glucose levels at the end of intervention & of those patients achieving remission of diabetes at the end of one year. Timepoint: six months one year 18 months

—

Secondary

Measure	Time frame
1.Change in time in range & glucose management indicator at the end 6 months of lifestyle intervention 2.Assessment of any complications of diabetes at the end of intervention 3.Change in body composition(muscle mass & fat mass) at the end of intervention (site specific- at Chellaram Diabetes Institute)Timepoint: six months	—

Countries

India

Contacts

Public ContactDrMayura Kale

Dr Kales Diabetes and Psychiatry Clinic

kalediabetesclinic@gmail.com09422713734

Outcome results

None listed

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