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

Sponsor
University Medical Centre Ljubljana (Other)
Overall Status
Completed
CT.gov ID
NCT03619330
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
8
Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Liraglutide and Testosterone Replacement Therapy on Features of Hypogonadism and Weight Loss in Obese Men With Persistent Features of Hypogonadism.
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.]

    2. 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.

    3. 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 Outcome Measures

    1. 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.]

    2. 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.

    Other Outcome Measures

    1. 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.

    2. 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.

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Ljubljana Ljubljana Slovenia 1000

    Sponsors and Collaborators

    • University Medical Centre Ljubljana

    Investigators

    • Principal Investigator: Andrej Janez, MD, PhD, University Medical Centre Ljubljana

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrej Janez, professor, MD, PhD, University Medical Centre Ljubljana
    ClinicalTrials.gov Identifier:
    NCT03619330
    Other Study ID Numbers:
    • TESTOSTERON
    First Posted:
    Aug 7, 2018
    Last Update Posted:
    Aug 7, 2018
    Last Verified:
    Aug 1, 2018
    Additional relevant MeSH terms:
    Hypogonadism
    Weight Loss
    Liraglutide
    Testosterone

    Study Results

    No Results Posted as of Aug 7, 2018