Clinical trial NCT02097680: Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men
Official title: Influence of the Aromatase Inhibitor Letrozole on Heart and Liver Function in Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: with disturbed glucose metabolism
without disturbed glucose metabolism
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility 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

Primary outcomes:
measure: cardiac function parameters
timeFrame: after 4 months intervention
measure: Hepatic function parameters
timeFrame: before intervention
measure: Hepatic function parameters
timeFrame: after 4 months intervention
measure: cardiac function parameters
timeFrame: before intervention
Secondary outcomes:
measure: glucose metabolism
timeFrame: Before four months intervention.
measure: weight
timeFrame: Before intervention.
measure: weight
timeFrame: after four months intervention.
measure: glucose metabolism
timeFrame: Before intervention.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Johannes Ruige, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: