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The purpose of this study was to determine whether liraglutide is more effective than metformin in the treatment of obese women with newly diagnosed polycystic ovary syndrome (PCOS). We anticipated greater changes in body weight in patients treated with liraglutide than in those treated with metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin | Active Comparator | In the MET 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 | Experimental | In the LIRA 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug |
|
| |
| 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 base point 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 |
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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 |
|---|---|
| D000069450 | Liraglutide |
| D012996 | Solutions |
| D007267 | Injections |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| metformin |
| 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. Comncetration 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. |
| Otehr 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 |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |