Research on Timing of Liraglutide Therapy in Patients With Obesity After Metabolic Surgery

Browse trials for

• Obesity 6,296
• Weight Loss 1,766

Keywords

• Liraglutide
• bariatric surgery
• obesity
• BMI
• GLP-1 receptor agonists

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.

Study arms

• Sham comparator
  control group

  Receive guidance on diet and exercise throughout the program, without the use of drugs

  Behavioral: Diet and exercise guidelines

• Experimental
  Liraglutide 6 month group

  Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 6 months.

  Drug: Liraglutide injection · Behavioral: Diet and exercise guidelines

• Experimental
  Liraglutide 9 month group

  Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 3 months of enrollment.

  Drug: Liraglutide injection · Behavioral: Diet and exercise guidelines

• Experimental
  Liraglutide 12 month group

  Receive guidance on diet and exercise throughout the program, started pharmacological intervention 6 months post 6 months of enrollment.

  Drug: Liraglutide injection · Behavioral: Diet and exercise guidelines

Interventions

• DrugLiraglutide injection

  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

Primary outcomes

1. Change in %TWL from baseline to endpoint across patient groups

   %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.

   Time frame: 48 weeks from enrollment

Secondary outcomes

1. Change in BMI from baseline to endpoint across patient groups

   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.

   Time frame: 48 weeks from enrollment

2. Change in body composition from baseline to endpoint across patient groups

   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.

   Time frame: 48 weeks from enrollment

3. Changes in blood pressure from baseline to endpoint

   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.

   Time frame: 48 weeks from enrollment

4. Changes in fasting blood glucose from baseline to endpoint

   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.

   Time frame: 48 weeks from enrollment

5. Change in HbA1c from baseline to endpoint across patient groups

   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.

   Time frame: 48 weeks from enrollment

Individual participant data

Plan to share: No — No participant data are available