Skip to main content
OpenTrials
Completed

NCT Number: NCT03269747

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prednisone

Drug

2 tablets of Prednisone 20 Mg in the morning

Placebo

Drug

2 Placebo tablets in the morning

Primary outcomes

  1. Cold induced thermogenesis

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

    : Increase in energy expenditure above resting metabolic rate in response to a mild cold stimulus determined by indirect calorimetry

Secondary outcomes

  1. fat fraction of supraclavicular BAT

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

    determined by MRI

  2. volume of supraclavicular BAT

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

    determined by MRI

  3. cold stimulated FGD uptake in brown adipose tissue

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

    determined as SUVmean by FDG-PET/CT

  4. SUVmax in the supraclavicular adipose tissue depot

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

    determined by FDG-PET/CT

Other outcomes

  1. Glucose level before and after mild cold stimulus

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

  2. FGF21 level before and after mild cold stimulus

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

  3. Expression levels of genes involved in thermogenesis and white to brown adipose tissue transdifferentiation in supraclavicular adipose tissue.

    Time frame: at the end of each treatment period (day 7). Prednisone vs. Placebo

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Acronym: GlucoBAT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2017
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.