Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
- Registration Number
- NCT03986008
- Lead Sponsor
- Xiangya Hospital of Central South University
- Brief Summary
The purpose of this studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Patients aged 18 to 65 years (to the date of screening)；
- The newly diagnosed obese patients (BMI greater than 28 kg/m2) or abdominal obesity (male waist circumference is greater than 90cm, female waist is greater than 85cm).
- Nearly a month have not used weight-related drugs,including various weight-loss drugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroid drugs,etc;Or recently used weight-related drugs but the stable dose was more than 1 month,and the drug dose remained constant or decreased during the trial.
- Weight stable for more than 3 months (weight fluctuations <5%).
Exclusion Criteria
- pregnant female.
- Secondary diseases caused by other diseases: including hypothyroidism, increased cortisol, hypothalamic and pituitary lesions caused by obesity, all kinds of drug-induced obesity, and others.
- Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
- Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
- Nearly a month had surgery, trauma, infection and so on.
- Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
- Poor medication compliance or serious side effects (severe rash, syncope, etc.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Benaglutide Benaglutide Benaglutide will be administered three times a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given 10 minutes before each meal. Liraglutide Liraglutide Liraglutide will be administered once a day by subcutaneous injection (under the skin) in the abdomen, thigh, or upper arm. It will be given independently of meals and preferably at the same each day.
- Primary Outcome Measures
Name Time Method Weight Change at 3 months baseline and 3 months Measured in kilograms
Gut microbiota composition 3 months Gut microbiota composition is assessed by 16S rRNA pyrosequencing. This analysis allows to obtain the relative abundance (%) of the different bacterial taxa and OTUs (operational taxonomic units).
- Secondary Outcome Measures
Name Time Method Change in tumor necrosis factor baseline and 3 months Measured in mmol/l
Change in lipids-low density lipoprotein cholesterol baseline and 3 months Measured in mmol/l
Change in lipids-high density lipoprotein cholesterol baseline and 3 months Measured in mmol/l
Change in lipids-free fatty acids baseline and 3 months Measured in μmol/l
Change in lipids-total cholesterol baseline and 3 months Measured in mmol/l
Change in waist circumference baseline and 3 months Measured in cm
Change in systolic blood pressure baseline and 3 months Measured in mmHg
Change in Uric Acid baseline and 3 months Measured in mmol/l
Change in interleukin-10 baseline and 3 months Measured in mmol/l
Change in lipids-triglycerides baseline and 3 months Measured in mmol/l
Change in diastolic blood pressure baseline and 3 months Measured in mmHg
Change in HbA1c baseline and 3 months Measured in %
Change in plasma glucose baseline and 3 months Measured in mmol/l
Change in insulin baseline and 3 months Measured in μU/ml
Trial Locations
- Locations (1)
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China