Incretin Hormones in PCOS With Prediabetes Clinical Trial
Official title:
Reduced GLP-1 Response is Associated With Prediabetes in Women With Adverse Metabolic Phenotype of PCOS Independently of BMI
| Verified date | June 2017 |
| Source | University Medical Centre Ljubljana |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | March 27, 2017 |
| Est. primary completion date | March 27, 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Slovenia | UMC Ljubljana | Ljubljana |
| Lead Sponsor | Collaborator |
|---|---|
| University Medical Centre Ljubljana |
Slovenia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 3h | |
| Secondary | 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. | 3h |