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Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men (HEPAROB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02097680
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : March 27, 2014
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

It seems plausible that increased aromatase activity in obese men, as a result of a larger fat mass, is responsible for decreased levels of testosterone. Therefore aromatase inhibition increases testosterone levels, which may affect hepatic and cardiac function.

In this intervention study two groups of hypogonadal obese men are compared. Group A is treated with Letrozole 2.5 mg (aromatase inhibitor) once every two days during four months; a group with normal testosterone and low oestrogen concentrations. Group B is treated with placebo once every two days during four months; this group will retain low testosterone - and high oestrogenic concentrations.

The primary objective of the study is to evaluate effects of changed sex steroids in obese men on hepatic and cardiac function.


Condition or disease Intervention/treatment Phase
Obesity Drug: Letrozole Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Influence of the Aromatase Inhibitor Letrozole on Heart and Liver Function in Obese Men
Study Start Date : December 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: Letrozole Drug: Letrozole
One Letrozole 2.5 mg capsule every two days during four months
Other Name: Femara

Placebo Comparator: Placebo comparator Drug: Placebo
One placebo capsule every two days during four months




Primary Outcome Measures :
  1. cardiac function parameters [ Time Frame: after 4 months intervention ]
    heart function will be measured by echocardiography.

  2. Hepatic function parameters [ Time Frame: before intervention ]
    Baseline sex steroids will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS) in fasting blood samples, before 10:00 am. Liver function will be analysed by a Nuclear Magnetic Resonance (NMR) recording

  3. Hepatic function parameters [ Time Frame: after 4 months intervention ]
    Baseline sex steroids will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS) in fasting blood samples, before 10:00 am. Liver function will be analysed by a Nuclear Magnetic Resonance (NMR) recording

  4. cardiac function parameters [ Time Frame: before intervention ]
    heart function will be measured by echocardiography.


Secondary Outcome Measures :
  1. glucose metabolism [ Time Frame: Before four months intervention. ]
    Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).

  2. weight [ Time Frame: Before intervention. ]
  3. weight [ Time Frame: after four months intervention. ]
  4. glucose metabolism [ Time Frame: Before intervention. ]
    Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese male subjects
  • Planned for gastric bypass (BMI > 30 kg/m²)
  • low testosterone levels
  • age between 20 and 65

Exclusion Criteria:

  • Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumours, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
  • Treatment with corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
  • Impaired renal function defined as serum-creatine > 1.5 mg/dL
  • Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
  • Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
  • Palpable prostate nodule or induration, Prostate-specific antigen (PSA) > 3 ng/mL, prostatism, untreated sleep apnea syndrome, erythrocytosis (hematocrit > 50%) or hyperviscosity. (cfr. Endocrine Society Clinical Practice Guideline by Bhasin S et al.)
  • Known or suspected abuse of alcohol or narcotics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02097680


Contacts
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Contact: Johannes Ruige, MD, PhD johannes.ruige@ugent.be
Contact: Marlies Bekaert 09/3323441 marlies.bekaert@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Sub-Investigator: Yves Van Nieuwenhove, MD, PhD         
Principal Investigator: Johannes Ruige, MD, PhD         
Sub-Investigator: Peter Smeets, MD         
Sub-Investigator: Tine De Backer, MD, PhD         
Sub-Investigator: Marlies Bekaert         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Johannes Ruige, MD, PhD University Hospital, Ghent

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT02097680    
Other Study ID Numbers: EC/2013/912
2013-002964-22 ( EudraCT Number )
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Keywords provided by University Hospital, Ghent:
with disturbed glucose metabolism
without disturbed glucose metabolism
Additional relevant MeSH terms:
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Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs