Effects of Benaglutide on Weight and Gut Microbiota in Obese Patients
NCT ID: NCT03986008
Last Updated: 2021-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
60 participants
INTERVENTIONAL
2019-12-01
2021-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Benaglutide
The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day.
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.
Liraglutide
The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day.
Interventions
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Benaglutide
The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day.
Liraglutide
The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.).
18 Years
65 Years
ALL
No
Sponsors
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Xiangya Hospital of Central South University
OTHER
Responsible Party
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Principal Investigators
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Jing Wu
Role: PRINCIPAL_INVESTIGATOR
Xiangya Hospital of Central South University
Locations
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Xiangya Hospital of Central South University
Changsha, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019050125
Identifier Type: -
Identifier Source: org_study_id
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