Research of Exenatide for Overweight/Obese PCOS Patients With IGR

NCT03352869 | Completed Phase 4

• 1 other identifier: [2017]077
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Overweight and Obesity; Disorder of Glucose Regulation

Keywords

Polycystic Ovary Syndrome; Overweight and Obesity; Impaired Glucose Regulation; Exenatide; Metformin

Outcome Measures

Primary Outcomes (1)

• Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation

  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%

  up to 12 weeks

Secondary Outcomes (3)

• Improvement of hyperandrogenism

  up to 12 weeks

• Improvement of blood lipid

  up to 12 weeks

• Improvement of fatty liver

  up to 12 weeks

Study Arms (3)

Exenatide

EXPERIMENTAL

Drug: Byetta Generic name: Exenatide Dosage form: 5ug and 10ug Dosage: 10-20ug/day Frequency: twice a day Duration: 3 months

Drug: Exenatide

Metformin

ACTIVE COMPARATOR

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

Drug: Metformin

Combination

EXPERIMENTAL

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

Drug: Exenatide; Drug: Metformin

Interventions

Exenatide DRUG

Use Exenatide for 3 months to treat PCOS

Also known as: Byetta

Combination; Exenatide

Metformin DRUG

Use Metformin for 3 months to treat PCOS

Also known as: Glucophage

Combination; Metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Department of Endocrinology and Metabolism

Shanghai, 200127, China

Location

Related Publications (8)

• Kahal H, Aburima A, Ungvari T, Rigby AS, Coady AM, Vince RV, Ajjan RA, Kilpatrick ES, Naseem KM, Atkin SL. The effects of treatment with liraglutide on atherothrombotic risk in obese young women with polycystic ovary syndrome and controls. BMC Endocr Disord. 2015 Apr 2;15:14. doi: 10.1186/s12902-015-0005-6.

  PMID: 25880805 BACKGROUND

• Elkind-Hirsch K, Marrioneaux O, Bhushan M, Vernor D, Bhushan R. Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Jul;93(7):2670-8. doi: 10.1210/jc.2008-0115. Epub 2008 May 6.

  PMID: 18460557 BACKGROUND

• Kahal H, Abouda G, Rigby AS, Coady AM, Kilpatrick ES, Atkin SL. Glucagon-like peptide-1 analogue, liraglutide, improves liver fibrosis markers in obese women with polycystic ovary syndrome and nonalcoholic fatty liver disease. Clin Endocrinol (Oxf). 2014 Oct;81(4):523-8. doi: 10.1111/cen.12369. Epub 2013 Dec 12.

  PMID: 24256515 BACKGROUND

• Jensterle M, Kocjan T, Kravos NA, Pfeifer M, Janez A. Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome. Endocr Res. 2015;40(3):133-8. doi: 10.3109/07435800.2014.966385. Epub 2014 Oct 20.

  PMID: 25330463 BACKGROUND

• Jensterle Sever M, Kocjan T, Pfeifer M, Kravos NA, Janez A. Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin. Eur J Endocrinol. 2014 Feb 7;170(3):451-9. doi: 10.1530/EJE-13-0797. Print 2014 Mar.

  PMID: 24362411 BACKGROUND

• Vitek W, Alur S, Hoeger KM. Off-label drug use in the treatment of polycystic ovary syndrome. Fertil Steril. 2015 Mar;103(3):605-11. doi: 10.1016/j.fertnstert.2015.01.019.

  PMID: 25726702 BACKGROUND

• Jensterle M, Kravos NA, Goricar K, Janez A. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. BMC Endocr Disord. 2017 Jan 31;17(1):5. doi: 10.1186/s12902-017-0155-9.

  PMID: 28143456 RESULT

• Tao T, Zhang Y, Zhu YC, Fu JR, Wang YY, Cai J, Ma JY, Xu Y, Gao YN, Sun Y, Fan W, Liu W. Exenatide, Metformin, or Both for Prediabetes in PCOS: A Randomized, Open-label, Parallel-group Controlled Study. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1420-e1432. doi: 10.1210/clinem/dgaa692.

  PMID: 32995892 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Overweight; Obesity

Interventions

Exenatide; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Tao Tao, MD

  RenJi Hospital Department of Endocrinology and Metabolism

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 24, 2017
• Study Start: November 28, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 31, 2018
• Last Updated: September 11, 2019

Record last verified: 2019-09

Locations

CN (1)