Clinical trial
Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
Name
IIT-2022-0245
Description
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 arms
Trial start
2023-02-23
Estimated PCD
2025-02-23
Trial end
2025-02-23
Status
Recruiting
Treatment
Liraglutide
Liraglutide is injected once a day.
Arms:
Liraglutide group
Semaglutide
Semaglutide is injected once a week.
Arms:
Semaglutide group
Metformin
Metformin is taken orally daily.
Arms:
Metformin group
Size
300
Primary endpoint
Blood glucose
The twelfth week of treatment
Blood insulin
The twelfth week of treatment
Total cholesterol
The twelfth week of treatment
Triglyceride
The twelfth week of treatment
Lipoprotein
The twelfth week of treatment
Weight
The twelfth week of treatment
Abdominal fat distribution
The twelfth week of treatment
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-05-16
1 organization
2 products
1 drug
10 indications
Organization
Renji HospitalProduct
LiraglutideIndication
MetforminIndication
ObesityIndication
AbdominalIndication
Diabetes MellitusIndication
Type 2Indication
Abdominal FatIndication
Nonalcoholic Fatty Liver DiseaseIndication
Metabolic DisorderIndication
Blood sugarIndication
LipidProduct
SemaglutideDrug
Metformin