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

Obesity Clinical Trial

— HEPAROB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097680
• Other study ID #: EC/2013/912
• Secondary ID: 2013-002964-22
• Status: Completed
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Letrozole
One Letrozole 2.5 mg capsule every two days during four months
• Placebo
One placebo capsule every two days during four months

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiac function parameters	heart function will be measured by echocardiography.	after 4 months intervention
Primary	Hepatic function parameters	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	before intervention
Primary	Hepatic function parameters	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	after 4 months intervention
Primary	cardiac function parameters	heart function will be measured by echocardiography.	before intervention
Secondary	glucose metabolism	Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).	Before four months intervention.
Secondary	weight		Before intervention.
Secondary	weight		after four months intervention.
Secondary	glucose metabolism	Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).	Before intervention.