Clinical trial NCT03986008: Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
Official title: Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-06-14
Enrollment: 60
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 studay is to evaluate the effects of Benaglutide on the treatment of subjects with obesity.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 65 years (to the date of screening)；
2. 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).
3. 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.
4. Weight stable for more than 3 months (weight fluctuations \<5%).

Exclusion Criteria:

1. pregnant female.
2. 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.
3. Severe cardiovascular and cerebrovascular diseases (heart failure, myocardial infarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease or pulmonary insufficiency, renal failure, severe hepatitis.
4. Combined with acute complications of diabetes such as ketoacidosis, lactic acidosis, hyperosmolar state of diabetes.
5. Nearly a month had surgery, trauma, infection and so on.
6. Limb deformity incomplete, difficult to accurately determine the height, weight and other physical indicators.
7. Poor medication compliance or serious side effects (severe rash, syncope, etc.).

Primary outcomes:
measure: Weight Change at 3 months
timeFrame: baseline and 3 months
measure: Gut microbiota composition
timeFrame: 3 months
Secondary outcomes:
measure: Change in waist circumference
timeFrame: baseline and 3 months
measure: Change in systolic blood pressure
timeFrame: baseline and 3 months
measure: Change in diastolic blood pressure
timeFrame: baseline and 3 months
measure: Change in HbA1c
timeFrame: baseline and 3 months
measure: Change in plasma glucose
timeFrame: baseline and 3 months
measure: Change in insulin
timeFrame: baseline and 3 months
measure: Change in lipids-total cholesterol
timeFrame: baseline and 3 months
measure: Change in lipids-low density lipoprotein cholesterol
timeFrame: baseline and 3 months
measure: Change in lipids-high density lipoprotein cholesterol
timeFrame: baseline and 3 months
measure: Change in lipids-triglycerides
timeFrame: baseline and 3 months
measure: Change in lipids-free fatty acids
timeFrame: baseline and 3 months
measure: Change in Uric Acid
timeFrame: baseline and 3 months
measure: Change in interleukin-10
timeFrame: baseline and 3 months
measure: Change in tumor necrosis factor
timeFrame: baseline and 3 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Jing Wu
role: PRINCIPAL_INVESTIGATOR
References: