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LIPT - Liraglutide in Polycystic Ovary Syndrome (LIPT)

Primary Purpose

Polycystic Ovary Syndrome, Cardiovascular Disease

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Liraglutide for 26 weeks

placebo

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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
...

Sites / Locations

Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital
Herlev Hospital, Dept of Gynecology
Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Liraglutide s.c. 1,8mg daily for 26 weeks

Placebo s.c. daily for 26 weeks

Outcomes

Primary Outcome Measures

Change in Endogenous Thrombin Potential (ETP)

Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min

Secondary Outcome Measures

Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1

Full Information

NCT ID

NCT02073929

First Posted

February 25, 2014

Last Updated

February 27, 2019

Sponsor

Jens Faber

1. Study Identification

Unique Protocol Identification Number

NCT02073929

Brief Title

LIPT - Liraglutide in Polycystic Ovary Syndrome

Acronym

LIPT

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

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jens Faber

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Cardiovascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active

Arm Type

Active Comparator

Arm Description

Liraglutide s.c. 1,8mg daily for 26 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo s.c. daily for 26 weeks

Intervention Type

Drug

Intervention Name(s)

Liraglutide for 26 weeks

Intervention Description

GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Placebo s.c. daily for 26 weeks

Primary Outcome Measure Information:

Title

Change in Endogenous Thrombin Potential (ETP)

Description

Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min

Time Frame

at time 0 and 26 weeks

Secondary Outcome Measure Information:

Title

Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1

Time Frame

at time 0 and 26 weeks

Other Pre-specified Outcome Measures:

Title

Change in Plasma Level of Adrenomedullin

Description

measured in nmol/l

Time Frame

at time 0 and 26 weeks

Title

Change in Plasma Level of Atrial Natriuretic Peptide (ANP)

Description

measured in pmol/l

Time Frame

at time 0 and 26 weeks

Title

Change in Plasma Level of Copeptin

Time Frame

at time 0 and 26 weeks

Title

Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP)

Description

percent change from baseline

Time Frame

at time 0 and 26 weeks

Title

Change in Bleeding Pattern (Bleeding Ratio)

Description

Ration between number of bleedings during 3 months before trial and last 3 months of trial

Time Frame

at time 0 and 26 weeks

Title

Change in Percent Liver Fat Content

Description

percent liver fat content

Time Frame

at time 0 and 26 weeks

Title

Change in Body Composition (VAT)

Description

cubic cm

Time Frame

at time 0 and 26 weeks

Title

Change in Ovarian Volume Between Baseline and Follow up (26 Weeks)

Description

measured as ml

Time Frame

at time 0 and 26 weeks

Title

Change in Serum Levels of Anti-Müllerian Hormone

Description

measured as pmol/l

Time Frame

at time 0 and 26 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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 ...

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jens Faber, DSc

Organizational Affiliation

Dept. of Medicine, Herlev Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Herlev Hospital, Dept of Gynecology

City

Herlev

ZIP/Postal Code

2730

Country

Denmark

Facility Name

Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital

City

Herlev

ZIP/Postal Code

DK-2730

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

28681988

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.

Results Reference

derived

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LIPT - Liraglutide in Polycystic Ovary Syndrome

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