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The purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than liraglutide or metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (PCOS) who had been previously poor responders regarding weight reduction on metformin monotherapy. We anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy with 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 1000 mg BID per os. |
|
| liraglutide | Active Comparator | In the liraglutide group liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week. |
|
| metformin and liraglutide | Active Comparator | In the metformin and liraglutide group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os. At the same time liraglutide was initiated at a dose of 0.6 mg injected sc once per day and increased to 1.2 mg/day after 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug |
|
| |
| liraglutide |
| Measure | Description | Time Frame |
|---|---|---|
| The main outcome was change in body weight. | 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 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 basepoint and every four weeks during the 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 |
|---|---|---|---|
| 25330463 | Derived | Jensterle M, Kocjan T, Kravos NA, Pfeifer M, Janez A. Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome. Endocr Res. 2015;40(3):133-8. doi: 10.3109/07435800.2014.966385. Epub 2014 Oct 20. |
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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 |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D052216 |
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| Drug |
|
|
| metformin and liraglutide | 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 basepoint and every four weeks during the 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 basepoint and every four weeks during the 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 basepoint and every four weeks during the 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 basepoint and every four weeks during the 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 basepoint and every four weeks during the 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 basepoint and every four weeks during the 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 basepoint and every four weeks during the 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 |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |