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

NCT03269747 | Completed Phase 4

• 1 other identifier: EKNZ 2016-01859
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Brown Adipose Tissue

Keywords

glucocorticoids; brown adipose tissue; cold induced thermogenesis

Outcome Measures

Primary Outcomes (1)

• Cold induced thermogenesis

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

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

Secondary Outcomes (4)

• fat fraction of supraclavicular BAT

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

• volume of supraclavicular BAT

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

• cold stimulated FGD uptake in brown adipose tissue

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

• SUVmax in the supraclavicular adipose tissue depot

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

Other Outcomes (3)

• Glucose level before and after mild cold stimulus

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

• FGF21 level before and after mild cold stimulus

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

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

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

Study Arms (2)

Prednisone

ACTIVE COMPARATOR

Prednisone 40 mg daily for 7 days

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Placebo daily for 7 days

Drug: Placebo

Interventions

Prednisone DRUG

2 tablets of Prednisone 20 Mg in the morning

Prednisone

Placebo DRUG

2 Placebo tablets in the morning

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

• Maushart CI, Sun W, Othman A, Ghosh A, Senn JR, Fischer JGW, Madoerin P, Loeliger RC, Benz RM, Takes M, Zech CJ, Chirindel A, Beuschlein F, Reincke M, Wild D, Bieri O, Zamboni N, Wolfrum C, Betz MJ. Effect of high-dose glucocorticoid treatment on human brown adipose tissue activity: a randomised, double-blinded, placebo-controlled cross-over trial in healthy men. EBioMedicine. 2023 Oct;96:104771. doi: 10.1016/j.ebiom.2023.104771. Epub 2023 Sep 4.

  PMID: 37659283 DERIVED

• Fischer JGW, Maushart CI, Becker AS, Muller J, Madoerin P, Chirindel A, Wild D, Ter Voert EEGW, Bieri O, Burger I, Betz MJ. Comparison of [18F]FDG PET/CT with magnetic resonance imaging for the assessment of human brown adipose tissue activity. EJNMMI Res. 2020 Jul 22;10(1):85. doi: 10.1186/s13550-020-00665-7.

  PMID: 32699996 DERIVED

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Matthias J Betz, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: December 6, 2017
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-06

Locations

CH (1)