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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Liraglutide s.c. 1,8mg daily for 26 weeks |
|
| Placebo | Placebo Comparator | Placebo s.c. daily for 26 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide for 26 weeks | Drug | GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1 | at time 0 and 26 weeks |
| 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 |
Inclusion Criteria:
Exclusion Criteria (including):
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| Name | Affiliation | Role |
|---|---|---|
| Jens Faber, DSc | Dept. of Medicine, Herlev Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Medicine and Dept. of Gyn-Obs, Herlev Hospital | Herlev | 2730 | Denmark | |||
| Herlev Hospital, Dept of Gynecology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28681988 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide | Liraglutide s.c. 1,8mg daily for 26 weeks Liraglutide: GLP-1-analogue Liraglutide |
| FG001 | Placebo | Placebo s.c. 1,8mg daily for 26 weeks placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide | Liraglutide |
| BG001 | Placebo | Placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Endogenous Thrombin Potential (ETP) | Area under curve in a Thrombin Generation Test (TGT). Measurements every min for 10 min | Posted | Mean | 95% Confidence Interval | nMolar x minutes | at time 0 and 26 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Liraglutide s.c. 1,8mg daily for 26 weeks Liraglutide: GLP-1-analogue Liraglutide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gallbladder stone attack | Hepatobiliary disorders | Systematic Assessment | gallbladder stone attack / gallstone related pain |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment | nausea in up-titrating phase |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Jens Faber | Center of Endocrinology and Metabolism, Dept. of Internal Medicine, Herlev Gentofte Hospital, Denmark | +4538689016 | jens.faber@regionh.dk |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| placebo |
| Drug |
Placebo s.c. daily for 26 weeks |
|
| 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 |
| Herlev |
| 2730 |
| Denmark |
| Dept. of Medicine and Dept. of Obstetrics and Gynaecology, Herlev Hospital | Herlev | DK-2730 | Denmark |
| Withdrawal by Subject |
|
| Total |
Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Total testosterone | Median | Inter-Quartile Range | nmol/l |
|
| Endogenous Thrombin Potential | Mean | Standard Deviation | micromol/l x min |
|
| Participants |
|
|
| Secondary | Percent Change in Plasma Level of Plasminogen Activator Inhibitor -1 PAI-1 | Posted | Mean | 95% Confidence Interval | percent change in plasma PAI-1 | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Plasma Level of Adrenomedullin | measured in nmol/l | Posted | Median | Inter-Quartile Range | nmol/l | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Plasma Level of Atrial Natriuretic Peptide (ANP) | measured in pmol/l | Posted | Median | Inter-Quartile Range | pmol/l | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Plasma Level of Copeptin | measured as pmol/l | Posted | Median | Full Range | pmol/l | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Percent Change in Plasma Level of High Sensitivity C-reactive Protein (CRP) | percent change from baseline | Posted | Mean | Inter-Quartile Range | percent change in CRP levels | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Bleeding Pattern (Bleeding Ratio) | Ration between number of bleedings during 3 months before trial and last 3 months of trial | Posted | Median | Inter-Quartile Range | n of bleedings/n of expected bleedings | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Percent Liver Fat Content | percent liver fat content | only participants with measurable i.e. >5% liver fat at baseline was included in this analysis | Posted | Mean | Standard Deviation | percentage of liver fat | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Body Composition (VAT) | cubic cm | not measured on all subjects (missing. 4 in Liraglutide and one in placebo Group) | Posted | Mean | Standard Deviation | cubic cm | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Ovarian Volume Between Baseline and Follow up (26 Weeks) | measured as ml | not measured in all participants, one is missing in each group | Posted | Mean | 95% Confidence Interval | ml | at time 0 and 26 weeks |
|
|
|
| Other Pre-specified | Change in Serum Levels of Anti-Müllerian Hormone | measured as pmol/l | missing one participant in placebo group | Posted | Mean | 95% Confidence Interval | pmol/ml | at time 0 and 26 weeks |
|
|
|
| 2 |
| 48 |
| 37 |
| 48 |
| EG001 | Placebo | Placebo s.c. 1,8mg daily for 26 weeks placebo | 1 | 24 | 3 | 24 |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| hypotension | General disorders | Systematic Assessment |
|
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |