Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-06

Study Completion Date

2019-04-16

Brief Summary

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Interventional, Placebo controlled cross-over study to investigate the short-term effects of glucocorticoids (prednisone) on human brown adipose tissue.

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Detailed Description

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Active brown adipose tissue (BAT) has recently been unambiguously discovered in human adults. Active BAT increases energy expenditure and improves glucose tolerance. Pharmacological use of glucocorticoids (GCs) is widespread in clinical practice due to their high anti-inflammatory efficacy. While short-term administration even of high doses usually is well tolerated, long-term use of medium to high amounts of GCs leads to unfavorable metabolic changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass and insulin resistance.

In line with these well-known side-effects of GCs, several in vitro studies and animal models demonstrate an inhibiting effect of GCs on BAT thermogenesis.

Conditions

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Brown Adipose Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prednisone

Prednisone 40 mg daily for 7 days

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type DRUG

2 tablets of Prednisone 20 Mg in the morning

Placebo

Placebo daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 Placebo tablets in the morning

Interventions

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Prednisone

2 tablets of Prednisone 20 Mg in the morning

Intervention Type DRUG

Placebo

2 Placebo tablets in the morning

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers
* BMI between 19-27 kg/m2

Exclusion Criteria

* Cold induced thermogenesis of less than 5% basal metabolic rate (determined during screening visit)
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* History of depressive disorder, anxiety disorder
* History of tuberculosis or latent infection
* Increased intraocular pressure
* History of peptic / gastrointestinal ulcer disease
* Concomitant medication: Non-steroidal anti-inflammatory drugs (NSAID), other glucocorticoids, diuretics, antihypertensives, fibrates or statins, metformin
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, diabetes mellitus),
* Hypersensitivity to cold (e.g. Raynaud Syndrome)
* Allergy to local anesthetic
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Hypothyroidism without sufficient substitution
* Claustrophobia
* MRI incompatible implants
* Enrolment into another study using ionizing radiation within the previous 12 months.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes