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

An open label parallel design randomized control trial of type 2 diabetes management with two-meals a day and exercise against the conventional multi-meal and exercise approach for effect on HbA1c and anti-diabetic medication in six months in newly detected diabetic subjects in a tertiary care Institute in Maharashtra. - RCT 2OMEX

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/04/051291
Enrollment
50
Registered
2023-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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: Modification of frequency of meals to only two meals per day: Subjects in this arm will be asked to take only 2 meals 8-10 hours apart in a day for the study duration. Control Intervent

Sponsors

SMBT IMS RC, Research Fund
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Change in HbA1cTimepoint: 1. At enrolment 2. At 60 days 3. At 120 days 4. AT 180 days—

Secondary

MeasureTime frame
Change in anti-diabetic medicationsTimepoint: 1. At enrolment 2. At 60 days 3. At 120 days 4. AT 180 days;Change in BMI and Waist circumferenceTimepoint: 1. At enrolment 2. At 60 days 3. At 120 days 4. AT 180 days—

Countries

India

Contacts

Public ContactDR AKHIL RAMESH PATIL

SMBT Institute of Medical sciences and Research centre, Dhamangaon, Nashik

akhilpatil3713@rediffmail.com9921030140

Outcome results

None listed

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