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Lifestyle Changes with Daily â?? two â?? only â?? Meals - and - Exercise for achieving remission in Type 2 Diabetes

A self - controlled trial with Lifestyle - Intervention of Daily â?? two â?? only â?? Meals - and - Exercise (2 - OMEX) for achieving remission in Type 2 Diabetes, measured by HbA1C Levels , in Gir-somnath District of Gujarat India - 2omex study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038424
Enrollment
75
Registered
2021-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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: 2OMEX Lifestyle Changes: â?? 2OMEX Lifestyle intervention: Two meals a day regime popularly known as â??Dixit dietâ?? will be advised to the patient as lifestyle intervention. In this p
with each meal in the order of: 6-8 dry fruits (no raisins, dates, apricot), then1 bowl salad (excluding beetroot, carrots), followed by 1 bowl of sprouted beans/pulses or 2 boiled eggs, and then all
diluted homemade buttermilk can be consumed in between these two meals.8 â?? Patient also has to strictly walk for minimum 4.5 km in 45 min every day. 8 â?? 2 OMEX lifestyle intervention is based on t

Sponsors

Health Department Gir Somnath District
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Those diagnosed with T2DM at least 1 month before the initiation of our study, belonging to the age group of 20-70 years, without any complications will be selected. Patients with HbA1C >5.7%, taking anti-diabetic medications/ insulin treatment. Patients with HbA1C >5.7%, not taking any treatment. The candidates who can self-report/report their daily findings with assistance of family member in 2-OMEX diary.

Exclusion criteria

Exclusion criteria: • Patients with cardiovascular disease, nephropathy, retinopathy, neuropathy diabetic foot, and also T2DM in pregnancy. • Those who do not give consent. • Those staying outside Gir Somnath District. • Those who would not be able to do physical activity/exercise for any reason of physical or feasibility issues.

Design outcomes

Primary

MeasureTime frame
To determine if 2- OMEX lifestyle causes significant decline of HbA1C levelsTimepoint: 6 months—

Secondary

MeasureTime frame
To determine if 2-OMEX lifestyle causes reduction in weight, waist to hip ratio, and requirement of anti-diabetic molecules/doses in six monthsTimepoint: 6 months—

Countries

India

Contacts

Public ContactDr Jatin Chhaya

GMERS Medical College, Junagadh, Gujarat India

dr.jatinchhaya@gmail.com

Outcome results

None listed

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