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

Shanghai Jiao Tong University

Status: Enrolling

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

Treatments: Drug: Semaglutide; Drug: Metformin; Drug: Liraglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT05779644

IIT-2022-0245

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Liraglutide group

Experimental group

Description:

Liraglutide is injected once a day.

Treatment:

Drug: Liraglutide

Semaglutide group

Experimental group

Description:

Semaglutide is injected once a week.

Treatment:

Drug: Semaglutide

Metformin group

Experimental group

Description:

Metformin is taken orally daily.

Treatment:

Drug: Metformin