Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Obesity, Abdominal; Diabetes Mellitus, Type 2; Abdominal Fat; Non-Alcoholic Fatty Liver Disease; Metformin; Metabolism Disorder, Glucose; Metabolism Disorder, Lipid
• Interventions: Drug: Liraglutide; Drug: Semaglutide; Drug: Metformin

• Registration Number: NCT05779644
• Lead Sponsor: RenJi Hospital

Brief Summary

The purpose of this study is to analyze the effects of GLP-1RA on blood glucose, body weight, glucose and lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes mellitus.

Detailed Description

Specific research contents: To study the characteristics of glucose and lipid metabolism and fat distribution in overweight/obesity patients with type 2 diabetes mellitus; liraglutide/ semaglutide/ metformin will be applied to patients for one year, and the changes of lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes and the differences among the three groups will be analyzed before and after treatment. The metabolomic changes of overweight/obese patients with type 2 diabetes before and after medication and the differences among the three groups will be analyzed. Explore the correlation between visceral fat content, glucose and lipid metabolism, inflammatory factors and other biochemical indicators and metabolomics.

Study Timeline

• Study Start: 2023-02-23
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-16
• Primary Completion: 2025-02-23
• Study Completion: 2025-02-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Aged 18-65 years old
• BMI≥24kg/㎡, or waist circumference: > 85cm (for male) or > 80cm (for female)
• Has been diagnosed with type 2 diabetes mellitus
• Good blood glucose control in recent three months: random blood sugar < 14mmol/L and HbA1c 6-9%
• Not received any drugs affecting glucose and lipid metabolism or weight loss surgery in the past one month

Exclusion Criteria

• Abnormal weight gain caused by other endocrine diseases
• Severe metabolic diseases, such as diabetic ketoacidosis, hypertonic hyperglycemia
• Type 1 diabetes or other special types of diabetes
• Used drugs affecting glycolipid metabolism in the past three months
• Severe bleeding tendency that unable to complete venous blood collection
• Patients with MRI contraindications
• Severe renal insufficiency or severe liver insufficiency
• Patients with advanced malignant tumors
• Serious cardiovascular and cerebrovascular diseases
• Rheumatic and immune diseases
• Pregnant and lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide group	Liraglutide	Liraglutide is injected once a day.
Semaglutide group	Semaglutide	Semaglutide is injected once a week.
Metformin group	Metformin	Metformin is taken orally daily.

Primary Outcome Measures

Name	Time	Method
Triglyceride	The twelfth week of treatment	Lipid metabolism index
Lipoprotein	The twelfth week of treatment	Lipid metabolism index
Blood glucose	The twelfth week of treatment	Glucose metabolism index
Total cholesterol	The twelfth week of treatment	Lipid metabolism index
Abdominal fat distribution	The twelfth week of treatment	Use Magnetic resonance imaging-proton density fat fraction to measure fat accumulation in the liver, pancreas and abdomen.
Blood insulin	The twelfth week of treatment	Glucose metabolism index
Weight	The twelfth week of treatment	Measure fasting weight

Trial Locations

Locations (1)

Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China