Clinical trial NCT05779644: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood glucose
timeFrame: The twelfth week of treatment
measure: Blood insulin
timeFrame: The twelfth week of treatment
measure: Total cholesterol
timeFrame: The twelfth week of treatment
measure: Triglyceride
timeFrame: The twelfth week of treatment
measure: Lipoprotein
timeFrame: The twelfth week of treatment
measure: Weight
timeFrame: The twelfth week of treatment
measure: Abdominal fat distribution
timeFrame: The twelfth week of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: