Clinical trial NCT02073929: LIPT - Liraglutide in Polycystic Ovary Syndrome
Official title: A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Cardiovascular Disease
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-02-28
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) affects 5-10% of women in fertile age. PCOS is associated with metabolic syndrom, diabetes and and increased risk og cardiovascular disease.

The study investigates the effect af intervention with GLP-1-analog on risk markers of cardiovascular disease in women with PCOS.

70 women will be included in af RCT.

Hypothesis: GLP-1-analog treatment in women with PCOS (without diabetes) will result in a beneficial reduction in risk markers of vascular thrombosis and early cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* PCOS
* \>18 years
* premenopausal
* BMI \>25 og 25 and thereunder + insulin resistent

Exclusion Criteria (including):

* actualt or intended pregnancy
* inadeqvat contraception
* hormonal contraception within 6 weeks
* metfoomin, GLP-1-analog or DPP IV inhibitor within 3 months
* medications affectiv hemostatic mechanisme
* diabetes or other severe comorbidity
* familar MEN
* ...

Primary outcomes:
measure: Change in Endogenous Thrombin Potential (ETP)
timeFrame: at time 0 and 26 weeks
Secondary outcomes:
measure: Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1
timeFrame: at time 0 and 26 weeks
Other outcomes:
measure: Change in Plasma Level of Adrenomedullin
timeFrame: at time 0 and 26 weeks
measure: Change in Plasma Level of Atrial Natriuretic Peptide (ANP)
timeFrame: at time 0 and 26 weeks
measure: Change in Plasma Level of Copeptin
timeFrame: at time 0 and 26 weeks
measure: Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)
timeFrame: at time 0 and 26 weeks
measure: Change in Bleeding Pattern (Bleeding Ratio)
timeFrame: at time 0 and 26 weeks
measure: Change in Percent Liver Fat Content
timeFrame: at time 0 and 26 weeks
measure: Change in Body Composition (VAT)
timeFrame: at time 0 and 26 weeks
measure: Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)
timeFrame: at time 0 and 26 weeks
measure: Change in Serum Levels of Anti-Müllerian Hormone
timeFrame: at time 0 and 26 weeks
Locations:
city: Herlev
country: Denmark
facility: Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital, Dept of Gynecology
city: Herlev
country: Denmark
facility: Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital
Study officials:
affiliation: Dept. of Medicine, Herlev Hospital
name: Jens Faber, DSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frossing S, Nylander M, Chabanova E, Frystyk J, Holst JJ, Kistorp C, Skouby SO, Faber J. Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial. Diabetes Obes Metab. 2018 Jan;20(1):215-218. doi: 10.1111/dom.13053. Epub 2017 Aug 11.