Research of Exenatide for Overweight/Obese PCOS Patients With IGR
Condition: Polycystic Ovary Syndrome; Overweight and Obesity; Disorder of Glucose Regulation
MeSH terms: Polycystic Ovary Syndrome; Overweight
Study type: Interventional
Phase: Phase 4

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 overweight/obese PCOS patients with impaired glucose regulation. The
      investigators plan to enroll 183 patients. Inclusion criteria: 1) Patients who have PCOS
      which is diagnosed according to 2003 Rotterdam criteria; 2) Overweight / obesity diagnostic
      criteria is based on WHO-WPR; 3) IGR diagnostic criteria is based on 1999 WHO diagnostic
      criteria; 4) have been treated with dietary and behavioral intervention for 3 months but are
      ineffective; 5) have no use of other hypoglycemic drugs before 3 months of treatment.

      Patients with 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 are excluded.

      Then the investigators plan to randomly divide the 183 patients into 3 groups: exenatide
      group, metformin group, and combination group, with 61 samples for each group. Each group use
      specific treatment (showed as the group name) for 3 months. Before and after the
      intervention, the blood samples would be collected to detect blood glucose, insulin, lipid
      profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as
      the anthropometric measurement and image examinations. All patients discontinue after 12
      weeks of treatment and only routine lifestyle intervention is performed after that. All
      patients receive 75 g OGTT test and insulin releasing test again 12 weeks after drug
      withdrawal to observe the IGR remission rate. To accurately assess the insulin secretion of
      islet β-cell, 13 patients would be randomly selected from MET group and from EX group
      respectively to receive the two-step hyperglycemic clamp before the intervention and after
      12-week treatment.

      The investigators will compare the data and finally identify the treatment effect of
      exenatide on PCOS patients.
    

Intervention name(s): Exenatide; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Use Exenatide for 3 months to treat PCOS; Use Metformin for 3 months to treat PCOS
Other intervention name(s): Byetta; Glucophage
Intervention MeSH terms: Metformin; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Overweight and Obesity; Impaired Glucose Regulation; Exenatide; Metformin