Influence of aromatase inhibitors on insulin sensitivity, liver and hart function in obese men
Conditions
Interventions
Trade Name: Femara
Product Name: Femara
Pharmaceutical Form: Capsule
INN or Proposed INN: LETROZOLE
CAS Number: 112809-51-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
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 - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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): - physical examination (length, weight, waist circumference, blood pressure and pulse) - insulin sensitivity - laboratory assessments - physical activity - sexual function - metabolic flexibility - NMR liver - 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): visit 1: T = 0 Visit 2: T = 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): There will be a pre- and post-intervention measurement of the tests (visit 1 and 2): - physical examination (blood pressure and pulse) - Insulin sensitivity - physical activity - NMR liver - 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): visit 1: T = 0 Visit 2: T = 4 months | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed