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GLP-1 Response in Women With PCOS and Prediabetes

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ClinicalTrials.gov Identifier: NCT03325569
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, 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.


Condition or disease Intervention/treatment Phase
Incretin Hormones in PCOS With Prediabetes Diagnostic Test: oral glucose tolerance test Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Reduced GLP-1 Response is Associated With Prediabetes in Women With Adverse Metabolic Phenotype of PCOS Independently of BMI
Actual Study Start Date : February 13, 2017
Actual Primary Completion Date : March 27, 2017
Actual Study Completion Date : March 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325569


Locations
Slovenia
UMC Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Andrej Janez, MD PhD University Medical Centre Ljubljana

Responsible Party: Andrej Janez, MD PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03325569     History of Changes
Other Study ID Numbers: IGH PCOS and inkretins
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia