GLP-1 Response in Women With PCOS and Prediabetes

October 24, 2017 updated by: Andrej Janez, University Medical Centre Ljubljana

Reduced GLP-1 Response is Associated With Prediabetes in Women With Adverse Metabolic Phenotype of PCOS Independently of BMI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: NGT
NGT - normal glucose tolerance. Women with PCOS and normal glucose tolerance
Diagnostic test: oral glucose tolerance test
GLP1 response to oral glucose load during oral glucose tolerance test was assessed.
ACTIVE_COMPARATOR: IGH
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
GLP1 response to oral glucose load during oral glucose tolerance test was assessed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.
Time Frame: 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.
3h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Study Chair: Andrej Janez, MD PhD, University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 13, 2017

Primary Completion (ACTUAL)

March 27, 2017

Study Completion (ACTUAL)

March 27, 2017

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 24, 2017

First Posted (ACTUAL)

October 30, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 24, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGH PCOS and inkretins

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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