Effects of Interleukin-1 Beta on Low Testosterone Levels in Men With Obesity and Metabolic Syndrome (TestIL)
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ClinicalTrials.gov Identifier: NCT02672592 |
Recruitment Status :
Completed
First Posted : February 3, 2016
Last Update Posted : July 13, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypogonadism Metabolic Syndrome X Obesity | Drug: Anakinra Drug: Sodium Chloride 0.9% | Phase 3 |
Obesity and the metabolic syndrome are considered as chronic low-grade inflammatory states. Elevated pro-inflammatory mediators in obesity and metabolic syndrome have an inhibitory effect on the hypothalamic-pituitary-gonadal axis (HPG axis) leading to hypogonadism. Decreased testosterone production in obese men in turn promotes additional fat deposition, contributing to a vicious cycle of fat accumulation. This complex pathophysiological interplay is termed hypogonadal-obesity-adipocytokine hypothesis, describing a bidirectional relationship between low levels of testosterone and the metabolic syndrome.
TestIL is a prospective, multicenter, randomized, double-blinded, placebo-controlled trial to test the hypothesis that inhibition of IL-1-activity diminishes the inhibitory effects on HPG axis and increases testosterone levels in men with metabolic syndrome.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Effects of IL-1 Beta on the Hypothalamic-pituitary-gonadal (HPG) Axis in Men With Obesity and Metabolic Syndrome - The TestIL Trial |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | June 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Anakinra
Anakinra//Kineret® 100mg s.c. bid
|
Drug: Anakinra
Anakinra 100mg s.c. bid
Other Name: KINERET |
Placebo Comparator: Placebo
Sodium Chloride 0.9% s.c. bid
|
Drug: Sodium Chloride 0.9%
Sodium Chloride 0.9% s.c. bid
Other Name: NaCl 0.9% |
- Total morning testosterone (nmol/l) [ Time Frame: 4 weeks ]
- Total morning testosterone (nmol/l) [ Time Frame: 1 week and 3 months ]
- Free testosterone (nmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]Assessed by equilibrium dialysis
- Bioavailable testosterone (nmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]Assessed by equilibrium dialysis
- Erectile dysfunction as assessed by International Index of Erectile Function (IIEF) score [ Time Frame: 1 week, 4 weeks and 3 months ]
- Clinical severity of hypogonadism as assessed by quantitative Androgen Deficiency in the Aging Male (qADAM) questionnaire [ Time Frame: 1 week, 4 weeks and 3 months ]
- Proportion of muscle mass as assessed by bioelectrical impedance Analysis [ Time Frame: 1 week, 4 weeks and 3 months ]
- Proportion of fat mass as assessed by bioelectrical impedance Analysis [ Time Frame: 1 week, 4 weeks and 3 months ]
- HbA1c (%) [ Time Frame: 1 week, 4 weeks and 3 months ]
- LH and FSH (IU/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Inhibin B, ACTH (pg/ml) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Prolactin, TSH, Insulin (mIU/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Interleukin-1, Interleukin-6 (pg/ml) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Cortisol basal (nmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- C-reactive protein (mg/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- free T4 (pmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- T3 (nmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- IGF-1 (nmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- GH (mU/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Androstendione (μg/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- DHEAS (μmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Oestradiol (pmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Oestron (ng/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- 17-OH-progesterone (nmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Copeptin (pmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Sex hormone-binding globulin (SHBG) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Muscle strength as assessed by grip strength test [ Time Frame: 1 week, 4 weeks and 3 months ]
- Waist-hip-ratio [ Time Frame: 1 week, 4 weeks and 3 months ]
- BMI in kg/m2 [ Time Frame: 1 week, 4 weeks and 3 months ]
- Insulin sensitivity as assessed by homeostasis model assessment insulin resistance (HOMA-IR) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides (mmol/l) [ Time Frame: 1 week, 4 weeks and 3 months ]
- Leptin (μg/l) [ Time Frame: 1 week, 4 weeks and 3 months ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent as documented by signature,
- Men at the age between 18 and 75 years,
- BMI >30 kg/m2 and at least 1 manifestation of the metabolic syndrome (i.e. prediabetes, diabetes, hypertension, dyslipidemia),
- Total testosterone level <12 nmol/l.
Exclusion Criteria:
- Previous or current medication with testosterone,
- 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,
- Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months,
- 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),
- Hematologic disease (leukocyte count < 1.5 x 109/l, hemoglobin < 11 g/dl, platelets <100 x 103/µl),
- Other clinically significant concomitant disease states (e.g., renal failure [Creatinine-Clearance < 30 ml/min], hepatic dysfunction [transaminases >3x upper normal range], active carcinoma,
- History of tuberculosis,
- Known or suspected non-compliance, drug or alcohol abuse,
- Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to anakinra/Kineret®,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- Previous enrolment into the current study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672592
Switzerland | |
University Department of Medicine, Kantonsspital Aarau | |
Aarau, Switzerland, 5001 | |
University Hospital Basel | |
Basel, Switzerland, 4031 |
Principal Investigator: | Mirjam Christ-Crain, Professor | Endocrinology, Diabetes and Metabolism; University Hospital Basel | |
Principal Investigator: | Beat Müller, Professor | University Department of Medicine; Kantonsspital Aarau |
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT02672592 |
Other Study ID Numbers: |
EKNZ 2015-376 |
First Posted: | February 3, 2016 Key Record Dates |
Last Update Posted: | July 13, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Metabolic syndrome X Hypogonadism Testosterone Inflammation Obesity |
Microvascular Angina Obesity Metabolic Syndrome Hypogonadism Syndrome Disease Pathologic Processes Overnutrition Nutrition Disorders Overweight Body Weight Insulin Resistance |
Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Gonadal Disorders Endocrine System Diseases Angina Pectoris Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |