GLP-1 Response in Women With PCOS and Prediabetes

NCT ID: NCT03325569

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-13

Study Completion Date

2017-03-27

Brief Summary

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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

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Conditions

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Incretin Hormones in PCOS With Prediabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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NGT

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

Group Type ACTIVE_COMPARATOR

oral glucose tolerance test

Intervention Type DIAGNOSTIC_TEST

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

IGH

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

Group Type ACTIVE_COMPARATOR

oral glucose tolerance test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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oral glucose tolerance test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Andrej Janez

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrej Janez, MD PhD

Role: STUDY_CHAIR

University Medical Centre Ljubljana

Locations

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UMC Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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IGH PCOS and inkretins

Identifier Type: -

Identifier Source: org_study_id