Hypogonadism, Obesity
Conditions
Brief summary
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.
Interventions
DRUGliraglutide
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.
DRUGTestosterone
In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
| 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 at the base point and every four weeks during 16 weeks of clinical trial. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of testosterone was measured in nmol/L. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary outcome was change in waist circumference. | Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial. | Patient's waist circumference was measured in centimeters. |
| 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. | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| The other outcomes was changes changes in fasting concentrations of glucose. | Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L. |
| Other outcome was change in HOMA IR index for insulin resistance. | Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial. | HOMA IR index was calculated as fasting plasma glucose times fasting plasma insulin devided by 22.5 |
| Other outcome was change in fasting concentration of insulin. | Patient's fasting blood was drawn at the basepoint and and the end of the 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. |
Countries
Slovenia
Outcome results
None listed