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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Completed

CT.gov ID

NCT02097680

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2013

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Letrozole	Drug: Letrozole One Letrozole 2.5 mg capsule every two days during four months Other Names: Femara
Placebo Comparator: Placebo comparator	Drug: Placebo One placebo capsule every two days during four months

Arm

Intervention/Treatment

Experimental: Letrozole

Drug: Letrozole

One Letrozole 2.5 mg capsule every two days during four months

Other Names:

Femara

Placebo Comparator: Placebo comparator

Drug: Placebo

One placebo capsule every two days during four months

Outcome Measures

Primary Outcome Measures

cardiac function parameters [after 4 months intervention]
heart function will be measured by echocardiography.
Hepatic function parameters [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
Hepatic function parameters [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
cardiac function parameters [before intervention]
heart function will be measured by echocardiography.

Secondary Outcome Measures

glucose metabolism [Before four months intervention.]
Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).
weight [Before intervention.]
weight [after four months intervention.]
glucose metabolism [Before intervention.]
Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT).

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent University Hospital	Ghent		Belgium	9000

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator: Johannes Ruige, MD, PhD, University Hospital, Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Ghent

ClinicalTrials.gov Identifier:

NCT02097680

Other Study ID Numbers:

EC/2013/912
2013-002964-22

First Posted:

Mar 27, 2014

Last Update Posted:

Jan 24, 2022

Last Verified:

Jan 1, 2022

Keywords provided by University Hospital, Ghent

with disturbed glucose metabolism

without disturbed glucose metabolism

Additional relevant MeSH terms:

Letrozole

Study Results

No Results Posted as of Jan 24, 2022