Research of Exenatide for Overweight/Obese PCOS Patients With IGR

Phase 4

Completed

• Conditions: Overweight and Obesity; Disorder of Glucose Regulation; Polycystic Ovary Syndrome
• Interventions: Drug: Exenatide; Drug: Metformin

• Registration Number: NCT03352869
• Lead Sponsor: RenJi Hospital

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-24
• Study Start: 2017-11-28
• Primary Completion: 2018-07-01
• Study Completion: 2018-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 183

Inclusion Criteria

1. 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exenatide	Exenatide	Drug: Byetta Generic name: Exenatide Dosage form: 5ug and 10ug Dosage: 10-20ug/day Frequency: twice a day Duration: 3 months
Combination	Exenatide	Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months
Metformin	Metformin	Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months
Combination	Metformin	Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months

Primary Outcome Measures

Name	Time	Method
Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation	up to 12 weeks	To compare the intravenous blood glucose of three groups 12 weeks after withdrawal. 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. Remission rate = Number of patients who has normal glucose tolerance 12 weeks after withdrawal / Number of patients who completed treatments × 100%

Secondary Outcome Measures

Name	Time	Method
Improvement of fatty liver	up to 12 weeks	To compare the number of fatty liver patients diagnosed by ultrasonography of three groups after 12-week treatment
Improvement of hyperandrogenism	up to 12 weeks	To compare the free androgen index (FAI =total serum testosterone x 100 / Sex Hormone Binding Globulin) of three groups after 12-week treatment
Improvement of blood lipid	up to 12 weeks	To compare the circulating lipid level(triglyceride, total cholesterol, HDL-C, LDL-C, etc.) of three groups after 12-week treatment

Trial Locations

Locations (1)

Renji Hospital Department of Endocrinology and Metabolism; 🇨🇳 Shanghai, China