---
title: Influence of Aromatase Inhibition on Hepatic- and Cardiac Function in Severe Obese Men
nct_id: NCT02097680
overall_status: COMPLETED
phase: PHASE4
sponsor: University Hospital, Ghent
study_type: INTERVENTIONAL
primary_condition: Obesity
countries: Belgium
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02097680.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02097680"
ct_last_update_post_date: 2022-01-24
last_seen_at: "2026-05-12T06:58:52.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02097680](https://clinicaltrials.gov/study/NCT02097680)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** University Hospital, Ghent
- **Conditions:** Obesity
- **Start Date:** 2013-12
- **Completion Date:** 2015-06
- **CT.gov Last Update:** 2022-01-24

## 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

- **Minimum age:** 20 Years
- **Maximum age:** 60 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Letrozole** (EXPERIMENTAL)
- **Placebo comparator** (PLACEBO_COMPARATOR)

## Interventions

- **Letrozole** (DRUG) — One Letrozole 2.5 mg capsule every two days during four months
- **Placebo** (DRUG) — One placebo capsule every two days during four months

## Primary Outcomes

- **cardiac function parameters** _(time frame: after 4 months intervention)_ — heart function will be measured by echocardiography.
- **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
- **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
- **cardiac function parameters** _(time frame: before intervention)_ — heart function will be measured by echocardiography.

## Secondary Outcomes

- **glucose metabolism** _(time frame: Before four months intervention.)_
- **weight** _(time frame: Before intervention.)_
- **weight** _(time frame: after four months intervention.)_
- **glucose metabolism** _(time frame: Before intervention.)_

## Locations (1)

- Ghent University Hospital, Ghent, Belgium

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ghent university hospital|ghent||belgium` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02097680.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02097680*  
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