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The purpose of this study was to compare the effects of liraglutide and testosterone replacement therapy on features of hypogonadism and weight loss in obese men with persistent features of hypogonadism after unsuccessful lifestyle measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liraglutide | Active Comparator | In the LIRA group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week. |
|
| testosterone | Active Comparator | In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | In the liraglutide group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The main outcome was improvements of symptoms related to hypogonadism | Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study. | |
| The main outcome was change testosterone level. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of testosterone was measured in nmol/L. | Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial. |
| the main outcome was change in gonadotropin levels. | Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial. |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary outcome was change in body weight. | Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial. | |
| The secondary outcome was change in waist circumference. | Patient's waist circumference was measured in centimeters. |
| 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 and the end of the 16 weeks of clinical trial. |
| Other outcome was change in fasting concentration of insulin. |
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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 |
|---|---|
| D007006 | Hypogonadism |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D012996 | Solutions |
| D007267 | Injections |
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Testosterone | Drug | In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin. |
|
|
| Patient's waist circumference was measured at the basepoint and every four weeks during 16 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 and the end of the 16 weeks of clinical trial. |
| Other outcome was change in HOMA IR index for insulin resistance. | HOMA IR index was calculated as fasting plasma glucose times fasting plasma insulin devided by 22.5 | Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial. |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |