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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779644
• Other study ID #: IIT-2022-0245
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: February 23, 2025

Study information

• Verified date: May 2023
• Source: RenJi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 23, 2025
• Est. primary completion date: February 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Fat
• Body Weight
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Disease
• Fatty Liver
• Glucose Metabolism Disorders
• Lipid Metabolism Disorders
• Liver Diseases
• Metabolic Diseases
• Metabolism Disorder, Glucose
• Metabolism Disorder, Lipid
• Metformin
• Non-Alcoholic Fatty Liver Disease
• Obesity, Abdominal
• Overweight

Intervention

Drug:
• Liraglutide
Liraglutide is injected once a day.
• Semaglutide
Semaglutide is injected once a week.
• Metformin
Metformin is taken orally daily.

Locations

Country	Name	City	State
China	Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	Glucose metabolism index	The twelfth week of treatment
Primary	Blood insulin	Glucose metabolism index	The twelfth week of treatment
Primary	Total cholesterol	Lipid metabolism index	The twelfth week of treatment
Primary	Triglyceride	Lipid metabolism index	The twelfth week of treatment
Primary	Lipoprotein	Lipid metabolism index	The twelfth week of treatment
Primary	Weight	Measure fasting weight	The twelfth week of treatment
Primary	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