AMH, Glucose Intolerance and Metabolic Syndrome in PCOS

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: serum

• Registration Number: NCT02676518
• Lead Sponsor: Chulalongkorn University

Brief Summary

Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)

Detailed Description

* To study the association between serum anti-Mullerian hormone (AMH) level and glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS).

* Glucose intolerance is detected by 2-hours 75 gram oral glucose tolerance test (OGTT).

* Metabolic syndrome is diagnosed by using the Harmonized criteria; the presence of any 3 of 5 following risk factors constitutes a diagnosis of metabolic syndrome.

1. Elevated waist circumference (\> 80 cm in Asian women)

2. Elevated triglycerides (\> 150 mg/dL)

3. Reduced HDL-cholesterol (\< 50 mg/dL)

4. Elevated blood pressure )systolic \> 130 and/or diastolic \> 85 mmHg)

5. Elevated fasting glucose ( \> 100 mg/dL)

* Percentage of glucose intolerance and metabolic syndrome in PCOS women as well was any differences in parameters between PCOS patients with and without glucose intolerance and metabolic syndrome will be analysed.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-19
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-03
• Last Update Submitted: 2016-02-03
• Study First Posted: 2016-02-08
• Last Update Posted: 2016-02-08
• Primary Completion: 2016-05
• Study Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• PCOS diagnosed by Rotterdam criteria 2003

Exclusion Criteria

• Pregnancy
• Previous any hormonal uses in the last 3 months
• Previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months
• Previous chemotherapy, ovarian surgery, pelvic irradiation
• Menopause

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
polycystic ovary syndrome women	serum	PCOS women diagnosed by Rotterdam criteria visiting the Gynecologic Unit at King Chulalongkorn Memorial Hospital and meet the inclusion criteria and no exclusion criteria of the study

Primary Outcome Measures

Name	Time	Method
Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome	6 months	Any differences between mean of serum AMH levels in PCOS with and without glucose intolerance and metabolic syndrome

Secondary Outcome Measures

Name	Time	Method
Percentage of metabolic syndrome in PCOS women	6 months	Percentage of metabolic syndrome defined by the Harmonized criteria in PCOS women
Percentage of glucose intolerance in PCOS women	6 months	Percentage of glucose intolerance detected by 75 g OGTT in PCOS women

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University; 🇹🇭 Bangkok, Thailand