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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03269747
Other study ID # EKNZ 2016-01859
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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