Comparison of Effect of Two-Only-Meals and Exercise(2-OMEX) against Conventional Multi-Meal Diet Pattern and Exercise lifestyle intervention on average three months blood sugar levels (HbA1c) among recently detected Type 2 Diabetic Patients

Comparison of Effect of Two-Only-Meals and Exercise against Conventional Multi-Meal Diet Pattern and Exercise on Glycosylated Hemoglobin Levels among Type 2 Diabetic Subjects: An Open Label Parallel Design Randomized Control Trial at Tertiary Care Institute Telangana

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/074688

Enrollment

160

Registered

2024-10-03

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: 2-OMEX lifestyle intervention Arm: follows only 2-OMEX-no snacking or energy drinks in between meals for 150 days out of 180 days, with no week having 2day break of 2- OMEX lifestyle in

Eligibility

Inclusion criteria

Inclusion criteria: 1.Recently detectedT2DM patients in last two year with HbA1c 7 to 8.5 gm%, yet to be started and/ or on antidiabetic medications and not on insulin with very minimal risk of hypoglycemia (as per American association of clinical endocrinology), BMI =25 kg/m2, 30- 55 years of age, both men and women (non-pregnant) 2. Willing to adopt 2-OMEX lifestyle and currently doing/willing to do mandatory moderate exercise and agreed to scheduled follow-up visits will be included.

Exclusion criteria

Exclusion criteria: 1.Participants already having renal and cardiac, nervous system comorbidity and/or on insulin,chronic diseases like uncontrolled thyroid disease, arthritis, hemoglobinopathies (Exclusion after assessment with renal, cardiac, nerve damage, liver and thyroid problems) and active, known malignancies within the last year (excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma), pregnancy or intention of becoming pregnant, breastfeeding, a history of any chronic disease process that could interfere with interpretation of study results, new hormonal supplementation or contraceptive hormonal medication changes in the last 2 months, type 1 diabetes mellitus or other forms of diabetes mellitus, alcohol abuse with more than 15 standard drinks per week, overnight shifts or intake of illicit substance. 2.Currently following specific/specialized diets for other health reasons, enrolled in other nutritional intervention studies, & use of medications that could affect nutritional status/appetite

Design outcomes

Primary

Measure	Time frame
Glycosylated Hemoglobin LevelsTimepoint: over a period of 180 days	—

Secondary

Measure	Time frame
Sugar levels Lipid profile Count & dosage of anti-diabetic medication BMI, Weight, Waist size Timepoint: over a period of 180 days	—

Countries

India

Contacts

Public ContactDR KUSNENIWAR GOVINDRAO NARSINGRAO

All India Institute of Medical Sciences

drkgn2012@gmail.com9985397984

Outcome results

None listed

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