LIPT - Liraglutide in Polycystic Ovary Syndrome (LIPT)

A Randomised, Double-blind, Placebo-controlled Study of the Effect of Liraglutide in Polycystic Ovary Syndrome on Risk Markers of Vascular Thrombosis.

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Polycystic Ovary Syndrome
• Intervention / Treatment: Drug: Liraglutide for 26 weeks; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital
  • Herlev, Denmark, 2730
    • Herlev Hospital, Dept of Gynecology
  • Herlev, Denmark, DK-2730
    • Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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
• ...

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active; Liraglutide s.c. 1,8mg daily for 26 weeks	Drug: Liraglutide for 26 weeks; GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks
Placebo Comparator: Placebo; Placebo s.c. daily for 26 weeks	Drug: placebo; Placebo s.c. daily for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Endogenous Thrombin Potential (ETP)	Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min	at time 0 and 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1	at time 0 and 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plasma Level of Adrenomedullin	measured in nmol/l	at time 0 and 26 weeks
Change in Plasma Level of Atrial Natriuretic Peptide (ANP)	measured in pmol/l	at time 0 and 26 weeks
Change in Plasma Level of Copeptin		at time 0 and 26 weeks
Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)	percent change from baseline	at time 0 and 26 weeks
Change in Bleeding Pattern (Bleeding Ratio)	Ration between number of bleedings during 3 months before trial and last 3 months of trial	at time 0 and 26 weeks
Change in Percent Liver Fat Content	percent liver fat content	at time 0 and 26 weeks
Change in Body Composition (VAT)	cubic cm	at time 0 and 26 weeks
Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)	measured as ml	at time 0 and 26 weeks
Change in Serum Levels of Anti-Müllerian Hormone	measured as pmol/l	at time 0 and 26 weeks

Collaborators and Investigators

• Sponsor: Jens Faber
• Investigators: Principal Investigator: Jens Faber, DSc, Dept. of Medicine, Herlev Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 25, 2014
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 28, 2014

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Cardiovascular Diseases; Polycystic Ovary Syndrome; Syndrome; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: EudraCT nr 2013-003862-15