Effects of IL-1 Beta on the HPA-axis in Obese Persons

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In obese individuals cortisol production and secretion is increased but the underlying mechanism is not known. Obesity leads to a pathological activation of the innate immune system partly driven by tissue production of IL-1β. Furthermore, IL-1β is also known to stimulate the release of adrenocorticotropin hormone (ACTH). Therefore, the investigators hypothesise that in obese individuals tissue inflammation stimulates ACTH via IL-1β, thereby explaining the observed hypercortisolism.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Corticosteroid-induced Lipodystrophy and Adipokines

NCT00822042

Lipodystrophy

COMPLETED

Pattern of Gene Expression in Adipose Tissue From Patients With Cushing Syndrome

NCT01688349

Cushing Syndrome Related to Cortisolic Adenoma

COMPLETED NA

NAC- NAFLD and Cushing

NCT05881005

Cushing Syndrome Fatty Liver Disease

RECRUITING NA

Effects of Tumor Necrosis Factor (TNF)-Alpha Antagonism in Patients With Metabolic Syndrome

NCT00111956

Metabolic Syndrome X

COMPLETED PHASE2/PHASE3

Natural Course of Initially Metabolic Healthy Obese Individuals (Healthy Obesity)?

NCT06799897

Healthy Obesity, Metabolically

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Syndrome Hypersecretion; Cortisol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anakinra

Anakinra 100mg s.c. x 5

Group Type EXPERIMENTAL

Anakinra

Intervention Type DRUG

Anakinra 100mg s.c. x 5

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Anakinra

Anakinra 100mg s.c. x 5

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 18-80 years
* BMI \>30kg/m2 and at least 1 manifestations of the metabolic syndrome (i.e. diabetes/ prediabetes, hypertension, dyslipidemia)
* Willingness to use contraceptive measures adequate to prevent becoming pregnant

Exclusion Criteria

* Medication with glucocorticosteroids
* Known Cushing Syndrome
* Pregnancy or breast feeding
* Clinical signs of infection in the week before inclusion or history of a severe infection during the last 2 months
* Hematologic disease (leukocyte count \< 1.5x109/l, hemoglobin \<11 g/dl, platelets \<100 x 103/ul)
* Kidney disease (creatinine-clearance \< 30ml/min))
* Liver disease (transaminases \>4x upper normal range)
* Active carcinoma
* History of tuberculosis
* Alcohol consumption \>40g/d for men, \>30g/d for women
* Known allergy towards anakinra
* Subject refusing or unable to give written informed consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No