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All the eligible participants after screening will be randomized into two groups (Group 1 and 2) by block randomization (block size of 4 and 6) using computer generated random number. Randomization is performed by the individual not involved in the study.
Participants in both groups will receive individual counselling sessions to help them adhere to a reduced-calorie diet (500-kcal deficit per day relative to the energy expenditure estimated at the time) and increased physical activity (with 150 minutes per week of physical activity, such as walking). Both diet and activity will be recorded daily in a diary or by use of a smartphone application or other tools and were reviewed during counselling sessions. Participants in group 1 also receive oral Semaglutide along with diet and exercise. Treatment will be initiated with the 3 mg once-daily dose. The dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on patient tolerance. Dose escalation schedule will be used to decrease the gastrointestinal side effects. Participants will be assessed for gastrointestinal complaints (nausea, vomiting) during escalation and follow-up. Once the desired dose is achieved, patient will remain at the maximum 14mg daily dose unless a reduction was warranted owing to problems with side effects. In such cases, investigators will reescalate the dose once symptoms are resolved or diminished.The absorption of oral Semaglutide is affected by food and fluid in the stomach, hence patients receiving oral Semaglutide will be instructed to take each tablet with up to 120 mL of water in the morning, in a fasting state, and a minimum of 30 min before the first meal of the day. Counselling will be done by a dietician or a similar qualified healthcare professional every 4th week via visits/phone contacts till the completion of the study. Participants have to physically visit the hospital at the end of 28 weeks for assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet+excercise+oral semaglutide | Experimental | Participants will receive individual counselling sessions for reduced-calorie diet and physical activity (with 150 minutes per week of physical activity, such as walking). Participants in this group will receive oral Semaglutide drug along with diet and exercise. Treatment will be initiated with the 3 mg once-daily dose. The dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on your symptoms (nausea, vomiting, constipation etc) |
|
| Diet+excercise | No Intervention | Participants in this group will receive individual counselling sessions for reduced-calorie diet and increased physical activity (with 150 minutes per week of physical activity, such as walking). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral semaglutide | Drug | Participants in Experimental group will receive oral Semaglutide along with diet and exercise. Treatment will be initiated with the 3 mg once-daily dose. The dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on patient tolerance. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients achieving a reduction in body weight of 5% or more from baseline | The proportion of patients achieving a reduction in body weight of 5% or more from baseline | seven months |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in body weight from baseline to week 28 | The percentage change in body weight will be compared between two groups. | Week 0 to week 28 |
| Achievement of body weight reduction greater than or equal to 10% (Yes/No) |
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Inclusion Criteria:
Exclusion Criteria:
• Diabetes mellitus
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rakesh kalapala, MD DNB | Contact | 9989211034 | drkalpala@gmail.com | |
| Anudeep Katrevula, MD DM | Contact | 9786025221 | anudeep.k65@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| chandana merugu, MD DM | Asian Institute of Gastroenterology Hospitals | Study Chair |
| pratik chhabra, MD | Asian Institute of Gastroenterology Hospitals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Institute of Gastroenterology hospitals | Recruiting | Hyderabad | Telangana | 500032 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41066034 | Derived | Katrevula A, Kalapala R, Agrawal S, Jagtap N, Chhabra P, Kulkarni AV, Merugu C, Katukuri GR, Duvvur NR. Oral semaglutide for weight loss and liver fibrosis in overweight and obesity: A randomized controlled trial. Indian J Gastroenterol. 2025 Oct 9. doi: 10.1007/s12664-025-01856-7. Online ahead of print. |
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Individuals identity will not be disclosed
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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|
Count of participants
| From baseline (week 0) to end of treatment (week 28) ] |
| Change in waist circumference | measured in cm | baseline (week 0) to end of treatment (week 28) |
| Change in body mass index (BMI) | measured in kg/m^2 | baseline (week 0) to end of treatment (week 28) |
| Change in systolic blood pressure | measured in mmHg | baseline (week 0) to end of treatment (week 28) |
| Change in diastolic blood pressure | measured in mmHg | baseline (week 0) to end of treatment (week 28) |
| Change in fasting serum insulin | Ratio to baseline | baseline (week 0) to end of treatment (week 28) |
| Rakesh kalapala, MD DNB |
| Asian Institute of Gastroenterology Hospitals |
| Principal Investigator |
| Nitin Jagtap, MD DNB | Asian Institute of Gastroenterology Hospitals | Study Chair |
| Anand V Kulkarni, MD DM | Asian Institute of Gastroenterology Hospitals | Study Chair |
| Anudeep Katrevula, MD DM | Asian Institute of Gastroenterology Hospitals | Study Chair |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |