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OpenTrials
Completed

NCT Number: NCT03325569

GLP-1 Response in Women With PCOS and Prediabetes

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.

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Key information

Conditions

Incretin Hormones in PCOS With Prediabetes

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral glucose tolerance test

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2017
Registry last updated
Oct 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.