Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2023
CompletedFirst Submitted
Initial submission to the registry
March 9, 2023
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2025
CompletedMay 16, 2023
May 1, 2023
2 years
March 9, 2023
May 12, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
Study Arms (3)
Liraglutide group
EXPERIMENTALLiraglutide is injected once a day.
Semaglutide group
EXPERIMENTALSemaglutide is injected once a week.
Metformin group
EXPERIMENTALMetformin is taken orally daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- RenJi Hospitallead
Study Sites (1)
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Endocrinology and Metabolism
Study Record Dates
First Submitted
March 9, 2023
First Posted
March 22, 2023
Study Start
February 23, 2023
Primary Completion
February 23, 2025
Study Completion
February 23, 2025
Last Updated
May 16, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share