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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Semaglutide
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liraglutide group<br>Liraglutide is injected once a day. | Drug: Liraglutide<br>* Liraglutide is injected once a day.<br>|
| Experimental: Semaglutide group<br>Semaglutide is injected once a week. | Drug: Semaglutide<br>* Semaglutide is injected once a week.<br>|
| Experimental: Metformin group<br>Metformin is taken orally daily. | Drug: Metformin<br>* Metformin is taken orally daily.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metformin, Glucagon-Like Peptide-1 Receptor, Obesity, Abdominal, Diabetes Mellitus, Type 2, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose