Last updated: April 7, 2021
Sponsor: Xiangya Hospital of Central South University
Overall Status: Active - Recruiting
Phase
3
Condition
Obesity
Diabetes Prevention
Treatment
N/AClinical Study ID
NCT03986008
2019050125
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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-lossdrugs,GLP-1 analogs or agonists,metformin, acarbose,insulin,anti hyperthyroiddrugs,etc;Or recently used weight-related drugs but the stable dose was more than 1month,and the drug dose remained constant or decreased during the trial.
- Weight stable for more than 3 months (weight fluctuations <5%).
Exclusion
Exclusion Criteria:
- pregnant female.
- Secondary diseases caused by other diseases: including hypothyroidism, increasedcortisol, hypothalamic and pituitary lesions caused by obesity, all kinds ofdrug-induced obesity, and others.
- Severe cardiovascular and cerebrovascular diseases (heart failure, myocardialinfarction, acute hemorrhagic or ischemic encephalopathy), pulmonary heart disease orpulmonary 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 andother physical indicators.
- Poor medication compliance or serious side effects (severe rash, syncope, etc.).
Study Design
Total Participants: 60
Study Start date:
December 01, 2019
Estimated Completion Date:
December 23, 2021
Connect with a study center
Xiangya Hospital of Central South University
Changsha, Hunan 410008
ChinaActive - Recruiting

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