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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Du Mengyang, MM; Phone Number: 18051756952; Email: dumengyang2022@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Anticipated): February 23, 2025
• Study Completion (Anticipated): February 23, 2025

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Metformin; Diabetes Mellitus, Type 2; Non-Alcoholic Fatty Liver Disease; Obesity, Abdominal; Glucagon-Like Peptide-1 Receptor; Metabolism Disorder, Glucose
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Obesity; Liver Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Disease; Fatty Liver; Overweight; Non-alcoholic Fatty Liver Disease; Body Weight; Metabolic Diseases; Lipid Metabolism Disorders; Obesity, Abdominal; Glucose Metabolism Disorders; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Metformin
• Other Study ID Numbers: IIT-2022-0245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No