Effect of frequency of meals on control of HbA1C in recently diagnosed type 2 diabetes mellitus patients

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2023/04/051291

Lead Sponsor: SMBT IMS RC, Research Fund

Brief Summary: Type 2 Diabetes is the rapidly growing non communicable disease in India, with preponement of age of commencement and early organ damage. The world needs ways to prevent Type 2 Diabetes epidemic and rollback of the disease. However, the rising prevalence of Type 2 Diabetes is evidence that both lifestyle and clinical management are facing challenges.

Conventional management of T2DM banks on small frequent meals, moderate exercise, and anti-diabetic medication (ADM). Many patients are now following a 2-meal a day frequency and moderate exercise (2OMEX) lifestyle with medication adjustments due to a popular campaign in Maharashtra, with a reported decline in HbA1c and even remission of Type 2 Diabetes. The recommendations strongly suggest that newly diagnosed diabetic subjects should receive a fair trial with lifestyle modification before initiating oral hypoglycaemic medication. Currently, various lifestyle modifications are popular including vegan diets, small diets for calorie restriction, intermittent fasting, and all with moderate daily/ weekly /5 days workouts.

The present study aims to test this hypothesis of Type 2 Diabetes control and remission in 2OMEX and conventional management arm, the main difference being frequency of meals (2 meals only or more than 2 meals as daily routine), while moderate exercise of 45 minutes (4.5 km walk) being common to both arms. We want to do this as an open label randomized clinical study, in a tertiary institute setting, OPD subjects detected recently with uncomplicated T2D with HbA1c between 7-10 gm% and on, none or two or less oral anti-diabetic medication molecules.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Recently detected Type 2 Diabetic patients willing to adopt change to two-meal and currently doing/willing to do mandatory exercise and without Nephropathy,cardiac involvement or neuropathy,not on insulin, HbA1c < 10gm%, yet to be started or on 2 or less anti-diabetic molecules.

Exclusion Criteria

Patients with Nephropathy,cardiac involvement or neuropathy Patients on insulin therapy, HbA1c > 10gm%, Patients on more than 2 anti-diabetic molecules.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	1. At enrolment \| 2. At 60 days \| 3. At 120 days \| 4. AT 180 days

Secondary Outcome Measures

Name	Time	Method
Change in anti-diabetic medications	1. At enrolment
Change in BMI and Waist circumference	1. At enrolment

Trial Locations

Locations (1): SMBT IMS RC, DHAMANGAON
🇮🇳
Nashik, MAHARASHTRA, India
SMBT IMS RC, DHAMANGAON
🇮🇳Nashik, MAHARASHTRA, India
Dr Akhil Patil
Principal investigator
9921030140
akhilpatil3713@rediffmail.com