NCT03949361

Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate whether treatment with glucocorticoids leads to a change in heat production of the human body at mild cold conditions.

Detailed description

Brown adipose tissue (BAT) is a thermogenic tissue that can convert chemical energy directly into heat due to the expression of uncoupling protein 1 (UCP1) protein. Data from preclinical studies shows that glucocorticoids (GCs) inhibit the function of BAT. In clinical practice GCs are often administered due tue their antiinflammatory properties making the investigation of short term (e.g. one week) and long therm (several months) effects practically relevant. This study's objective is to evaluate the effect of glucocorticoid treatment on cold induced thermogenesis (CIT) in humans.

Conditions

• Thermoregulation Impairment

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Indirect calorimetry	Resting energy expenditure
DIAGNOSTIC_TEST	Skin Temperature	Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer
DIAGNOSTIC_TEST	Dual energy X-ray Absorptiometry (DXA)	Body composition
DIAGNOSTIC_TEST	Blood Sampling	thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
DIAGNOSTIC_TEST	FDG-PET	Dynamic PET scanning of the neck-region
DIAGNOSTIC_TEST	Capillary glucose	Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
DIAGNOSTIC_TEST	Biopsy of supraclavicular adipose tissue (optional)	Ultrasound guided biopsy of the supraclavicular adipose tissue

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-05-14
• Last updated: 2022-01-25

Locations

1 site across 1 country: Switzerland