Back to resultsGLP-1 Response in Women With PCOS and Prediabetes
Primary Purpose
Incretin Hormones in PCOS With Prediabetes
Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
oral glucose tolerance test
Sponsored by
About this trial
This is an interventional screening trial for Incretin Hormones in PCOS With Prediabetes
Eligibility 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
Sites / Locations
- UMC Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
NGT
IGH
Arm Description
NGT - normal glucose tolerance. Women with PCOS and normal glucose tolerance
IGH - impaired glucose homeostasis Women with PCOS and impaired glucose homeostasis - that means impaired fasting glucose or impaired glucose tolerance.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.
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.
Full Information
NCT ID
NCT03325569
First Posted
October 24, 2017
Last Updated
October 24, 2017
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT03325569
Brief Title
GLP-1 Response in Women With PCOS and Prediabetes
Official Title
Reduced GLP-1 Response is Associated With Prediabetes in Women With Adverse Metabolic Phenotype of PCOS Independently of BMI
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 13, 2017 (Actual)
Primary Completion Date
March 27, 2017 (Actual)
Study Completion Date
March 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incretin Hormones in PCOS With Prediabetes
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NGT
Arm Type
Active Comparator
Arm Description
NGT - normal glucose tolerance. Women with PCOS and normal glucose tolerance
Arm Title
IGH
Arm Type
Active Comparator
Arm Description
IGH - impaired glucose homeostasis Women with PCOS and impaired glucose homeostasis - that means impaired fasting glucose or impaired glucose tolerance.
Intervention Type
Diagnostic Test
Intervention Name(s)
oral glucose tolerance test
Intervention Description
GLP1 response to oral glucose load during oral glucose tolerance test was assessed.
Primary Outcome Measure Information:
Title
The main outcome was difference in fasting and after load GLP1 levels between two groups
Description
Patient GLP1 levels were measured at base point and in 120 min of 75-g OGTT. GLP1 levels were compared between groups
Time Frame
3h
Secondary Outcome Measure Information:
Title
The secondary outcome was to evaluate the between group difference in beta cell function, and visceral adipose tissue.
Description
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.
Time Frame
3h
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Janez, MD PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Study Chair
Facility Information:
Facility Name
UMC Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
12. IPD Sharing Statement
Plan to Share IPD
No
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GLP-1 Response in Women With PCOS and Prediabetes
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