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The purpose of this study was to determine whether monotherapy treatment with phosphodiesterase-4 (PDE-4) inhibitor roflumilast is more effective than treatment with glucagon-like protein 1 (GLP-1) liraglutide or treatment with metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding weight reduction who have not been treated before. The investigators anticipated greater changes in body weight in patients on roflumilast treatment than in liraglutide or metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Active Comparator | In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 2x1000 mg BID per os. |
|
| liraglutide | Active Comparator | In the liraglutide group liraglutide was initiated at a dose of 0,6mg sc once per day for one week and increased to 1,2mg sc one per day. |
|
| roflumilast | Active Comparator | In the roflumilast group roflumilast was initiated at a dose of 500 mg BID per os. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug |
|
| |
| liraglutide |
| Measure | Description | Time Frame |
|---|---|---|
| The main outcome was change in body weight. | The patient's body weight was measured in kilograms. | Patient's body weight was mesured at the base point and every four weeks during 12 weeks of clinical trial. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome was change in body mass index (BMI). | Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters. | Patient's body weight were measured at the basepoint and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint. |
| Measure | Description | Time Frame |
|---|---|---|
| The other outcomes was changes in fasting concentrations of glucose. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| Other outcome was change in fasting concentration of insulin. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrej Janez, MD, PhD | University Medical Centre Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26032655 | Derived | Jensterle M, Salamun V, Kocjan T, Vrtacnik Bokal E, Janez A. Short term monotherapy with GLP-1 receptor agonist liraglutide or PDE 4 inhibitor roflumilast is superior to metformin in weight loss in obese PCOS women: a pilot randomized study. J Ovarian Res. 2015 Jun 2;8:32. doi: 10.1186/s13048-015-0161-3. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000069450 | Liraglutide |
| C424423 | Roflumilast |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D052216 |
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| Drug |
|
|
| roflumilast | Drug |
|
|
| The secondary outcome was change in waist circumference. |
Patient's waist circumference was measured in centimeters. |
| Patient's waist circumference was measured at the basepoint and every four weeks during 12 weeks of clinical trial. |
Patient's blood was drawn between 8 and 9 a.m. Fasting concentrations of insulin was measured in mU/L. |
| Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| Other outcome was change in blood concentrations of LH (luteinizing hormone). | Patient's blood was drawn between 8 and 9 a.m. Concentration of LH was measured in U/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| Other outcome was change in blood concentrations of FSH (follicle-stimulating hormone). | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of FSH was measured in U/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| Other outcome was change in blood concentration of testosterone. | Patient's blood was drawn between 8 and 9 a.m. Blood concentration was measured in nmol/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| Other outcome was change in blood concentration in androstenedione. | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of androstenedione was measured in nmol/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| Other outcome was change in blood concentrations of SHBG (sex hormone-binding globulin). | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of SHBG was measured in nmol/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| Other outcome was change in blood concentration of DHEAS (dehydroepiandrosterone sulfate). | Patient's blood was drawn between 8 and 9 a.m. Blood concentrations of DHEAS was measured in micromol/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |