Influence of aromatase inhibitors on insulin sensitivity, liver and hart function in obese me
- Conditions
- Influence of aromatase inhibitors on insulin sensitivity, liver and hart function in obese menTherapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2013-002964-22-BE
- Lead Sponsor
- Ghent University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
All criteria should be met
1)Informed consent obtained.
2)Obese male subjects planned for gastric bypass with low testosterone levels
3)Age 20 - 65 , BMI > 30 kg/m²
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- 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
- Impaired liver function, defined as ALAT > 2.5 times upper limit of normal
- 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, PSA > 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit > 50%) or hyperviscosity. (cfr. Endocrine Society Clinical Practice Guideline by Bhasin S et al. ref. 10)
- Known or suspected abuse of alcohol or narcotics
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to evaluate potential effects and causes of changed sex steroids in obese men;Secondary Objective: Does a change of the sex steroid environment in obese men have an impact on liver and heart function? Is there a direct (independent of body weight) influence on insulin sensitivity?;Primary end point(s): There will be a pre- and post-intervention measurement of the tests (visit 1 and 2):<br>- physical examination (length, weight, waist circumference, blood pressure and pulse)<br>- insulin sensitivity<br>- laboratory assessments<br>- physical activity<br>- sexual function<br>- metabolic flexibility<br>- NMR liver<br>- Echocardiography;Timepoint(s) of evaluation of this end point: There will be a pre- and post-intervention measurement of the tests (visit 1 and 2):<br>visit 1: T = 0<br>Visit 2: T = 4 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): There will be a pre- and post-intervention measurement of the tests (visit 1 and 2):<br>- physical examination (blood pressure and pulse)<br>- Insulin sensitivity<br>- physical activity<br>- NMR liver<br>- Echocardiography;Timepoint(s) of evaluation of this end point: There will be a pre- and post-intervention measurement of the tests (visit 1 and 2):<br>visit 1: T = 0<br>Visit 2: T = 4 months