AMH, Glucose Intolerance and Metabolic Syndrome in PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Anti-Müllerian Hormone and Its Association With Glucose Intolerance and Metabolic Syndrome in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02676518
• Other study ID #: 057/2015
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: February 3, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: February 2016
• Source: Chulalongkorn University
• Contact: Wasamon Tunsuparp, MD
• Phone: 66850658502
• Email: wasamontun[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Metabolic Syndrome X
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• serum
Serum for serum anti-Mullerian hormone, 2-hour 75 gram oral glucose tolerance test and lipid profiles

Locations

Country	Name	City	State
Thailand	Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome	Any differences between mean of serum AMH levels in PCOS with and without glucose intolerance and metabolic syndrome	6 months
Secondary	Percentage of glucose intolerance in PCOS women	Percentage of glucose intolerance detected by 75 g OGTT in PCOS women	6 months
Secondary	Percentage of metabolic syndrome in PCOS women	Percentage of metabolic syndrome defined by the Harmonized criteria in PCOS women	6 months