Clinical Trials Logo
  1. Home
  2. Diabetes Mellitus, Type 2
  3. NCT05779644
  4. Details
NCT05779644 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05779644
Other study ID # IIT-2022-0245
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 23, 2023
Est. completion date February 23, 2025

Study information
Verified date May 2023
Source RenJi Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date February 23, 2025
Est. primary completion date February 23, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liraglutide
Liraglutide is injected once a day.
• Semaglutide
Semaglutide is injected once a week.
• Metformin
Metformin is taken orally daily.

Locations
Country Name City State
China Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blood glucose Glucose metabolism index The twelfth week of treatment
Primary Blood insulin Glucose metabolism index The twelfth week of treatment
Primary Total cholesterol Lipid metabolism index The twelfth week of treatment
Primary Triglyceride Lipid metabolism index The twelfth week of treatment
Primary Lipoprotein Lipid metabolism index The twelfth week of treatment
Primary Weight Measure fasting weight The twelfth week of treatment
Primary 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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05666479 - CGM Monitoring in T2DM Patients Undergoing Orthopaedic Replacement Surgery
Completed NCT05647083 - The Effect of Massage on Diabetic Parameters N/A
Active, not recruiting NCT05661799 - Persistence of Physical Activity in People With Type 2 Diabetes Over Time. N/A
Completed NCT03686722 - Effect of Co-administration of Metformin and Daclatasvir on the Pharmacokinetis and Pharmacodynamics of Metformin Phase 1
Completed NCT02836704 - Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) Phase 4
Completed NCT01819129 - Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes Phase 3
Completed NCT04562714 - Impact of Flash Glucose Monitoring in People With Type 2 Diabetes Using Non-Insulin Antihyperglycemic Therapy N/A
Completed NCT02009488 - Treatment Differences Between Canagliflozin and Placebo in Insulin Secretion in Subjects With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT05896319 - Hyaluronic Acid Treatment of the Post-extraction Tooth Socket Healing in Subjects With Diabetes Mellitus Type 2 N/A
Recruiting NCT05598203 - Effect of Nutrition Education Groups in the Treatment of Patients With Type 2 Diabetes N/A
Completed NCT05046873 - A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People Phase 1
Terminated NCT04090242 - Impact of App Based Diabetes Training Program in Conjunction With the BD Nano Pen Needle in People With T2 Diabetes N/A
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Completed NCT03620357 - Continuous Glucose Monitoring & Management In Type 2 Diabetes (T2D) N/A
Completed NCT03604224 - A Study to Observe Clinical Effectiveness of Canagliflozin 300 mg Containing Treatment Regimens in Indian Type 2 Diabetes Participants With BMI>25 kg/m^2, in Real World Clinical Setting
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Completed NCT03620890 - Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy Phase 4
Withdrawn NCT05473286 - A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice
Not yet recruiting NCT05029804 - Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes N/A
Completed NCT04531631 - Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes Phase 2