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

NCT02097680 | Completed Phase 4

• 2 other identifiers: EC/2013/9122013-002964-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

with disturbed glucose metabolism; without disturbed glucose metabolism

Outcome Measures

Primary Outcomes (4)

• cardiac function parameters

  heart function will be measured by echocardiography.

  after 4 months intervention

• 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

• 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

• cardiac function parameters

  heart function will be measured by echocardiography.

  before intervention

Secondary Outcomes (4)

• glucose metabolism

  Before four months intervention.

• weight

  Before intervention.

• weight

  after four months intervention.

• glucose metabolism

  Before intervention.

Study Arms (2)

Letrozole

EXPERIMENTAL

Drug: Letrozole

Placebo comparator

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Letrozole DRUG

One Letrozole 2.5 mg capsule every two days during four months

Also known as: Femara

Letrozole

Placebo DRUG

One placebo capsule every two days during four months

Placebo comparator

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Obesity

Interventions

Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johannes Ruige, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 27, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: January 24, 2022

Record last verified: 2022-01

Locations

BE (1)