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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002964-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole | Experimental |
| |
| Placebo comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | One Letrozole 2.5 mg capsule every two days during four months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| glucose metabolism | Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT). | Before four months intervention. |
| weight | Before intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johannes Ruige, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Placebo | Drug | One placebo capsule every two days during four months |
|
| weight | after four months intervention. |
| glucose metabolism | Glucose metabolism will be estimated by an oral glucose tolerance test (OGTT). | Before intervention. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |