Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT02672592
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent as documented by signature,
2. Men at the age between 18 and 75 years,
3. BMI \>30 kg/m2 and at least 1 manifestation of the metabolic syndrome (i.e. prediabetes, diabetes, hypertension, dyslipidemia),
4. Total testosterone level \<12 nmol/l.
Exclusion Criteria:
1. Previous or current medication with testosterone,
2. Testosterone deficiency of other cause, i.e. primary hypogonadism caused e.g. by Klinefelters syndrome, cryptorchidism, condition following orchiectomy. Known secondary hypogonadism caused by pituitary adenoma. Patients on antiandrogen medication,
3. Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months,
4. Severe immunosuppression (e.g. patients with previously known infection with human immunodeficiency virus and a cluster of differentiation 4 (CD4) count below 350 x 109/L, patients on immunosuppressive therapy after solid organ transplantation and neutropenic patients with neutrophil count \< 500 x 109/L and patients under chemotherapy with neutrophils 500-1000 x 109/L with an expected decrease to values \< 500 x 109/L),
5. Hematologic disease (leukocyte count \< 1.5 x 109/l, hemoglobin \< 11 g/dl, platelets \<100 x 103/µl),
6. Other clinically significant concomitant disease states (e.g., renal failure \[Creatinine-Clearance \< 30 ml/min\], hepatic dysfunction \[transaminases \>3x upper normal range\], active carcinoma,
7. History of tuberculosis,
8. Known or suspected non-compliance, drug or alcohol abuse,
9. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to anakinra/Kineret®,
10. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
11. Previous enrolment into the current study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02672592
Study Brief:
Protocol Section:
NCT02672592