Bariatric Surgery, Obesity, Weight Loss
Conditions
Keywords
Liraglutide, bariatric surgery, obesity, BMI, GLP-1 receptor agonists
Brief summary
The goal of this clinical trial is to compare the weight loss and metabolic benefit in patients remaining obesity at 6 months after metabolic surgery. The main questions it aims to answer are: \[primary hypothesis 1\] Whether liraglutide benefits weight loss when it is initiated early after metabolic surgery. \[primary hypothesis 2\] Whether weight loss and metabolic benefits are greater when linaglutide is initiated in patients who are obese at 6 months after metabolic surgery
Interventions
Patients received a 24-week regimen of once-daily liraglutide, initiated at 0.6 mg/day and titrated weekly by 0.6 mg to a maximum tolerated dose of up to 3.0 mg/day.
BEHAVIORALDiet and exercise guidelines
Participants followed a science-based diet and exercise program intervention
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients 6 months after metabolic surgery; * 18 years ≤ age ≤ 65 years; * Body Mass Index (BMI) ≥ 28 kg/m\^2
Exclusion criteria
* allergy to liraglutide, severe hepatic or renal impairment (eGFR \<60 mL/min/1.73 m² or ALT/AST ≥3× ULN) * history of medullary thyroid carcinoma, MEN-2 or other malignancies * pancreatitis or severe gastrointestinal disease, pregnancy or lactation * use of anti-obesity drugs or other interventional trials within 3 months or major uncontrolled illness * Patients were discontinued if withdrawn, intolerant, lost to follow-up, or developed severe adverse events.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in %TWL from baseline to endpoint across patient groups | 48 weeks from enrollment | %TWL = (\[baseline weight - weight at follow-up\]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the percentage of weight loss from the baseline. The mean and standard deviation of %TWL were calculated for subjects within each group. Subsequently, intergroup comparisons were performed to calculate p-values. If p \< 0.05, pairwise comparisons were further conducted. Based on the final results, the differences in weight loss among groups were evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI from baseline to endpoint across patient groups | 48 weeks from enrollment | BMI = Weight / Height\^2 weight and height will be combined to report BMI in kg/m\^2 (Weight is measured in kilograms, height in meters, and BMI is expressed in kilograms per square meter) The observed metric is the difference obtained by subtracting the endpoint BMI from the baseline BMI. Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons. |
| Change in body composition from baseline to endpoint across patient groups | 48 weeks from enrollment | body composition (Including body fat, fat-free mass, skeletal muscle, etc.; in kilograms） Body composition values at the endpoint minus baseline values are used as the change metric to evaluate body composition changes (These indicators are used to assess the body composition improvement of patients) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons. |
| Changes in blood pressure from baseline to endpoint | 48 weeks from enrollment | Difference between the endpoint blood pressure and the baseline value.(blood pressure in mmHg; This indicator is used to assess improvements in a patient's blood pressure.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons. |
| Changes in fasting blood glucose from baseline to endpoint | 48 weeks from enrollment | Difference between endpoint fasting blood glucose and baseline value (blood glucose in mmol/L; This indicator is used to assess improvements in patients' fasting blood glucose levels.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons. |
| Change in HbA1c from baseline to endpoint across patient groups | 48 weeks from enrollment | Difference between the endpoint HbA1c value and the baseline value (HbA1c in percentage, This indicator is used to assess improvements in a patient's HbA1c levels.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons. |
Countries
China
Outcome results
None listed