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

August 6, 2018 updated by: Andrej Janez, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: liraglutide
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.
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.
Other Names:
  • Victoza 6 mg/ml solution for injection in pre-filled pen
Active Comparator: testosterone
In the ANDRO group testosterone was initiated at a dose of 50 mg in a gel form once daily.
Drug: Testosterone
In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.
Other Names:
  • Androtop gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main outcome was improvements of symptoms related to hypogonadism
Time Frame: Patients were screened and asked for symptoms at the beginning and every 4 weeks for 16 weeks of the study.
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.
Time Frame: 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.
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.
Time Frame: Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.
Patient's blood was drawn at the base point and every four weeks during 16 weeks of clinical trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome was change in body weight.
Time Frame: Patient's body weight in kilograms were measured at the base point and every four weeks during the 16 weeks of clinical trial.
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.
Time Frame: 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.
Patient's waist circumference was measured at the basepoint and every four weeks during 16 weeks of clinical trial.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The other outcomes was changes changes in fasting concentrations of glucose.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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
Patient's fasting blood was drawn at the basepoint and and the end of the 16 weeks of clinical trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 6, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESTOSTERON

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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