Status:
COMPLETED
Research of Exenatide for Overweight/Obese PCOS Patients With IGR
Lead Sponsor:
RenJi Hospital
Conditions:
Polycystic Ovary Syndrome
Overweight and Obesity
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Compare the therapeutic effects of exenatide, metformin and their combination for 3 months on reproductive and metabolic improvements of overweight/obese PCOS patients with impaired glucose regulation...
Detailed Description
The investigators designed a randomized control trial to compare the therapeutic effects of exenatide, metformin and their combination for 3 months on reproductive and metabolic improvements of overwe...
Eligibility Criteria
Inclusion
- have PCOS which is diagnosed according to 2003 Rotterdam criteria;
- overweight / obesity diagnostic criteria is based on WHO-WPR ;
- IGR diagnostic criteria is based on 1999 WHO diagnostic criteria;
- have been treated with dietary and behavioral intervention for 3 months but are ineffective;
- have no use of other hypoglycemic drugs before 3 months of treatment.
Exclusion
- Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months)
- high blood pressure (\>160/100mmHg)
- active infection
- secondary diabetes
- pregnancy
- alcohol abuse
- allergic to GLP-1 receptor agonist or metformin
Key Trial Info
Start Date :
November 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT03352869
Start Date
November 28 2017
End Date
July 31 2018
Last Update
September 11 2019
Active Locations (1)
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1
Renji Hospital Department of Endocrinology and Metabolism
Shanghai, China, 200127