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

Sponsor

RenJi Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05779644

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glucagon-Like Peptide-1 Receptor Metformin Obesity, Abdominal Diabetes Mellitus, Type 2 Abdominal Fat Non-Alcoholic Fatty Liver Disease Metabolism Disorder, Glucose Metabolism Disorder, Lipid	Drug: Liraglutide Drug: Semaglutide Drug: Metformin	N/A

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/Smiglutide/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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 23, 2023

Anticipated Primary Completion Date :

Feb 23, 2025

Anticipated Study Completion Date :

Feb 23, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liraglutide group Liraglutide is injected once a day.	Drug: Liraglutide Liraglutide is injected once a day.
Experimental: Semaglutide group Semaglutide is injected once a week.	Drug: Semaglutide Semaglutide is injected once a week.
Experimental: Metformin group Metformin is taken orally daily.	Drug: Metformin Metformin is taken orally daily.

Arm

Intervention/Treatment

Experimental: Liraglutide group

Liraglutide is injected once a day.

Drug: Liraglutide

Liraglutide is injected once a day.

Experimental: Semaglutide group

Semaglutide is injected once a week.

Drug: Semaglutide

Semaglutide is injected once a week.

Experimental: Metformin group

Metformin is taken orally daily.

Drug: Metformin

Metformin is taken orally daily.

Outcome Measures

Primary Outcome Measures

Glucose and Lipid metabolism index [The twelfth week of treatment]
blood glucose, insulin, total cholesterol, triglyceride, and lipoprotein.
Weight [The twelfth week of treatment]
Measure fasting weight
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Aged 18-65 years old; 2.BMI≥24kg/㎡, or waist circumference: > 85cm (for male) or > 80cm (for female); 3. Has been diagnosed with type 2 diabetes mellitus; 4. 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:

1. Abnormal weight gain caused by other endocrine diseases; 2. Severe metabolic diseases, such as diabetic ketoacidosis, hypertonic hyperglycemia; 3.Type 1 diabetes or other special types of diabetes; 4.Used drugs affecting glycolipid metabolism in the past three months; 5. Severe bleeding tendency that unable to complete venous blood collection; 6. Patients with MRI contraindications; 7. Severe renal insufficiency or severe liver insufficiency; 8. Patients with advanced malignant tumors; 9. Serious cardiovascular and cerebrovascular diseases; 10. Rheumatic and immune diseases; 11. Pregnant and lactating women.