E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Influence of aromatase inhibitors on insulin sensitivity, liver and hart function in obese men |
|
E.1.1.1 | Medical condition in easily understood language |
obesity
insulun sensitivity, liver and heart function
sex steroids |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of the study is to evaluate potential effects and causes of changed sex steroids in obese men |
|
E.2.2 | Secondary objectives of the trial |
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? |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
|
E.4 | Principal 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.
|
|
E.5 End points |
E.5.1 | 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 |
|
E.5.1.1 | 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 |
|
E.5.2 | 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 |
|
E.5.2.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
end of trial = visit 2 (T = 4 months) |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |