GLP-1 Response in Women With PCOS and Prediabetes

NCT03325569 | Completed

• 1 other identifier: IGH PCOS and inkretins
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Incretin Hormones in PCOS With Prediabetes

Outcome Measures

Primary Outcomes (1)

• The main outcome was difference in fasting and after load GLP1 levels between two groups

  Patient GLP1 levels were measured at base point and in 120 min of 75-g OGTT. GLP1 levels were compared between groups

  3h

Secondary Outcomes (1)

• The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.

  3h

Study Arms (2)

NGT

ACTIVE COMPARATOR

NGT - normal glucose tolerance. Women with PCOS and normal glucose tolerance

Diagnostic Test: oral glucose tolerance test

IGH

ACTIVE COMPARATOR

IGH - impaired glucose homeostasis Women with PCOS and impaired glucose homeostasis - that means impaired fasting glucose or impaired glucose tolerance.

Diagnostic Test: oral glucose tolerance test

Interventions

oral glucose tolerance test DIAGNOSTIC_TEST

GLP1 response to oral glucose load during oral glucose tolerance test was assessed.

IGH; NGT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Andrej Janez, MD PhD

  University Medical Centre Ljubljana

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 30, 2017
• Study Start: February 13, 2017
• Primary Completion: March 27, 2017
• Study Completion: March 27, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)