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

Phase 3

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

• Registration Number: CTRI/2023/08/056621
• Lead Sponsor: Chellaram Diabetes Research Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 < 200 mg/dL

5.Heamoglobin percentage between 8.5-16 gm/d

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 <60 ml/min , CKD – EPI equation), known malignancy, hemodynamic instability, hospitalized patients,

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 < 8.5% or >16%

7.Participants having fasting C peptide level < 0.8 ng/mL, HbA1C <6.5% 0r >9.0%,

Fasting blood glucose >200 mg/d

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of patients achieving normalisation of blood glucose levels with nutritional intervention consisting of healthy local sustainable diet. <br/ ><br>2. Percentage of patients achieving remission of type 2 diabetes with nutritional intervention consisting of healthy local sustainable diet. <br/ ><br>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. <br/ ><br>Timepoint: six months <br/ ><br>one year <br/ ><br>18 months <br/ ><br>

Secondary Outcome Measures

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