GLP-1 Response in Women With PCOS and Prediabetes

Not Applicable

Completed

• Conditions: Incretin Hormones in PCOS With Prediabetes
• Interventions: Diagnostic Test: oral glucose tolerance test

• Registration Number: NCT03325569
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

Women with PCOS are more prone to obesity which exacerbates insulin resistance, the abdominal fat disposition and metabolic risk of these patients. With development of obesity these women have high conversion rate from normal glucose tolerance to impaired glucose tolerance and in turn to type 2 diabetes.

Glucagon-like peptide 1 (GLP-1) is involved in body weight maintenance. Beside energy balance it is also involved in glucose homeostasis. Functional deficit in GLP-1 facilitates obesity. We investigated the link between the concentration of incretin hormones and glucose homeostasis, metabolic complications and the distribution of body composition in obese women with PCOS.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-13
• Primary Completion: 2017-03-27
• Study Completion: 2017-03-27
• Status Verified: 2017-06
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Last Update Submitted: 2017-10-24
• Study First Posted: 2017-10-30
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26

Inclusion Criteria

• 18 years old to menopause
• polycystic ovary sindrome (NICHD criteria)
• BMI of 30 kg/m2 or higher

Exclusion Criteria

• type 1 or type 2 diabetes mellitus
• Cushing's syndrome or congenital (non-classic) adrenal hyperplasia
• personal or family history of MEN 2
• the use of medications known or suspected to affect reproductive or metabolic functions
• the use of statins within 90 days prior to study entery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IGH	oral glucose tolerance test	IGH - impaired glucose homeostasis Women with PCOS and impaired glucose homeostasis - that means impaired fasting glucose or impaired glucose tolerance.
NGT	oral glucose tolerance test	NGT - normal glucose tolerance. Women with PCOS and normal glucose tolerance

Primary Outcome Measures

Name	Time	Method
The main outcome was difference in fasting and after load GLP1 levels between two groups	3h	Patient GLP1 levels were measured at base point and in 120 min of 75-g OGTT. GLP1 levels were compared between groups

Secondary Outcome Measures

Name	Time	Method
The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.	3h	At base point visceral adipose tissue (VAT) mass, volume and area were measured with DXA. To assess beta cell function static and dynamic parameters of beta cell function were calculated.

Trial Locations

Locations (1)

UMC Ljubljana; 🇸🇮 Ljubljana, Slovenia