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Completed

NCT Number: NCT02097680

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

letrozole

Drug

One Letrozole 2.5 mg capsule every two days during four months

Other names: Femara

Placebo

Drug

One placebo capsule every two days during four months

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

Influence of the Aromatase Inhibitor Letrozole on Heart and Liver Function in Obese Men

Acronym: HEPAROB

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 27, 2014
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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