Testosterone Replacement Therapy and Liraglutide Effects on Weight Loss in Hypogonadism.

Obesity Clinical Trial

Official title:

Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619330
• Other study ID #: TESTOSTERON
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: August 2015

Study information

• Verified date: August 2018
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Related Conditions & MeSH terms

• Hypogonadism
• Obesity
• Weight Loss

Intervention

Drug:
• liraglutide
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.
• Testosterone
In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Other outcome was change in fasting concentration of insulin.	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	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.
Primary	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.
Primary	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.
Primary	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.
Secondary	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.
Secondary	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 16 weeks of clinical trial.