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

Brown Adipose Tissue Clinical Trial

— GlucoBAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269747
• Other study ID #: EKNZ 2016-01859
• Status: Completed
• Phase: Phase 4
• Start date: December 6, 2017
• Est. completion date: April 16, 2019

Study information

• Verified date: June 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 16, 2019
• Est. primary completion date: April 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brown Adipose Tissue

Intervention

Drug:
• Prednisone
2 tablets of Prednisone 20 Mg in the morning
• Placebo
2 Placebo tablets in the morning

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Department of Endocrinology	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glucose level before and after mild cold stimulus		at the end of each treatment period (day 7). Prednisone vs. Placebo
Other	FGF21 level before and after mild cold stimulus		at the end of each treatment period (day 7). Prednisone vs. Placebo
Other	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
Primary	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	fat fraction of supraclavicular BAT	determined by MRI	at the end of each treatment period (day 7). Prednisone vs. Placebo
Secondary	volume of supraclavicular BAT	determined by MRI	at the end of each treatment period (day 7). Prednisone vs. Placebo
Secondary	cold stimulated FGD uptake in brown adipose tissue	determined as SUVmean by FDG-PET/CT	at the end of each treatment period (day 7). Prednisone vs. Placebo
Secondary	SUVmax in the supraclavicular adipose tissue depot	determined by FDG-PET/CT	at the end of each treatment period (day 7). Prednisone vs. Placebo