Obesity, Weight Loss
Conditions
Brief summary
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.
Interventions
DRUGoral semaglutide
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.
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Consecutive consenting patients of both genders with either a BMI of 30 or greater or a BMI of 27 or greater with one or more treated or untreated weight-related coexisting conditions (i.e., prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).
Exclusion criteria
* • Diabetes mellitus * A glycated haemoglobin level of 48 mmol per mole (6.5%) or greater, * A history of chronic pancreatitis * Acute pancreatitis within 180 days before enrolment * Previous surgical obesity treatment * Use of antiobesity medication within 90 days before enrolment * Pregnancy and planning for pregnancy * Known malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving a reduction in body weight of 5% or more from baseline | seven months | The proportion of patients achieving a reduction in body weight of 5% or more from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of body weight reduction greater than or equal to 10% (Yes/No) | From baseline (week 0) to end of treatment (week 28) ] | Count of participants |
| Change in waist circumference | baseline (week 0) to end of treatment (week 28) | measured in cm |
| Change in body mass index (BMI) | baseline (week 0) to end of treatment (week 28) | measured in kg/m\^2 |
| The percentage change in body weight from baseline to week 28 | Week 0 to week 28 | The percentage change in body weight will be compared between two groups. |
| Change in diastolic blood pressure | baseline (week 0) to end of treatment (week 28) | measured in mmHg |
| Change in fasting serum insulin | baseline (week 0) to end of treatment (week 28) | Ratio to baseline |
| Change in systolic blood pressure | baseline (week 0) to end of treatment (week 28) | measured in mmHg |
Countries
India
Contacts
Primary ContactRakesh kalapala, MD DNB
Backup ContactAnudeep Katrevula, MD DM
Outcome results
None listed