Back to resultsEffects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
Primary Purpose
Metformin, Obesity, Abdominal, Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Liraglutide
Semaglutide
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Metformin focused on measuring Metformin, Glucagon-Like Peptide-1 Receptor, Obesity, Abdominal, Diabetes Mellitus, Type 2, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose
Eligibility Criteria
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
Sites / Locations
- Ren Ji Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Liraglutide group
Semaglutide group
Metformin group
Arm Description
Liraglutide is injected once a day.
Semaglutide is injected once a week.
Metformin is taken orally daily.
Outcomes
Primary Outcome Measures
Blood glucose
Glucose metabolism index
Blood insulin
Glucose metabolism index
Total cholesterol
Lipid metabolism index
Triglyceride
Lipid metabolism index
Lipoprotein
Lipid metabolism index
Weight
Measure fasting weight
Abdominal fat distribution
Use Magnetic resonance imaging-proton density fat fraction to measure fat accumulation in the liver, pancreas and abdomen.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05779644
Brief Title
Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
Official Title
Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
February 23, 2025 (Anticipated)
Study Completion Date
February 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metformin, Obesity, Abdominal, Diabetes Mellitus, Type 2, Abdominal Fat, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose, Metabolism Disorder, Lipid
Keywords
Metformin, Glucagon-Like Peptide-1 Receptor, Obesity, Abdominal, Diabetes Mellitus, Type 2, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Liraglutide group
Arm Type
Experimental
Arm Description
Liraglutide is injected once a day.
Arm Title
Semaglutide group
Arm Type
Experimental
Arm Description
Semaglutide is injected once a week.
Arm Title
Metformin group
Arm Type
Experimental
Arm Description
Metformin is taken orally daily.
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
Liraglutide is injected once a day.
Intervention Type
Drug
Intervention Name(s)
Semaglutide
Intervention Description
Semaglutide is injected once a week.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin is taken orally daily.
Primary Outcome Measure Information:
Title
Blood glucose
Description
Glucose metabolism index
Time Frame
The twelfth week of treatment
Title
Blood insulin
Description
Glucose metabolism index
Time Frame
The twelfth week of treatment
Title
Total cholesterol
Description
Lipid metabolism index
Time Frame
The twelfth week of treatment
Title
Triglyceride
Description
Lipid metabolism index
Time Frame
The twelfth week of treatment
Title
Lipoprotein
Description
Lipid metabolism index
Time Frame
The twelfth week of treatment
Title
Weight
Description
Measure fasting weight
Time Frame
The twelfth week of treatment
Title
Abdominal fat distribution
Description
Use Magnetic resonance imaging-proton density fat fraction to measure fat accumulation in the liver, pancreas and abdomen.
Time Frame
The twelfth week of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Du Mengyang, MM
Phone
18051756952
Email
dumengyang2022@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
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