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Completed

NCT Number: NCT03949361

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

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.

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Key information

Conditions

Thermoregulation Impairment

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel, Department of Endocrinology

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Planned therapy with at least 7.5 mg prednisone equivalent per day or higher for more than 28 days (group A)
  • Planned weaning off glucocorticoid therapy which lasted al least 28 days with a dosage of at least 7.5 mg prednisone (group B)
  • BMI 19-30 kg/m2
  • Informed Consent as documented by signature

Exclusion criteria

  • Insufficient thyroid hormone substitution in case of hypothyroidism
  • Uncontrolled diabetes mellitus (HbA1c >7.5%)
  • Severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer
  • Known hypersensitivity to cold, e.g. primary or secondary Raynaud's Syndrome
  • Known or suspected non-compliance
  • Abuse of alcohol or illicit drugs
  • Claustrophobia
  • Women who are pregnant or breast feeding
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc of the participant
  • Previous enrolment into the current study
  • Enrolment into another study using ionizing radiation within the previous 12 months

Treatment and study plan

indirect calorimetry

Diagnostic Test

Resting energy expenditure

Skin Temperature

Diagnostic Test

Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer

Dual energy X-ray Absorptiometry (DXA)

Diagnostic Test

Body composition

Blood sampling

Diagnostic Test

thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)

FDG-PET

Diagnostic Test

Dynamic PET scanning of the neck-region

Capillary glucose

Diagnostic Test

Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia

Biopsy of supraclavicular adipose tissue (optional)

Diagnostic Test

Ultrasound guided biopsy of the supraclavicular adipose tissue

Primary outcomes

  1. Cold-induced thermogenesis (CIT) under glucocorticoids

    Time frame: Change from glucocortoid start to +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

    Comparison of CIT change off-glucocorticoids with warm ischemia time (WIT) on-glucocorticoids by using indirect calorimetry. Comparing two Groups (Observation group A and B) we will address the CIT change from glucocorticoid start to 4-8 weeks into treatment (group A) and the CIT change from glucocorticoid therapy to weaning off upon more than 3 months after glucocorticoid withdrawal (group B)

Secondary outcomes

  1. Resting metabolic rate (RMR)

    Time frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

    Comparison of RMR of patients starting GCs or patients stopping GCs, measured by indirect calorimetry

  2. Body composition

    Time frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

    Comparison of body composition concerning muscle mass and fat mass, determined by DXA

  3. Cold stimulated glucose uptake into supraclavicular BAT

    Time frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

    Determination of 'standardized uptake value' (SUV) mean in two volumes of interest on the supraclavicular adipose tissue, after PET-CT

  4. SUV max in supraclavicular adipose tissue depot

    Time frame: Baseline and +4 to 8 weeks into treatment/ +3 months after weaning off GCs (resp.)

    Determination of SUV max in the supraclavicular adipose tissue, after positron emission tomography (PET)-CT

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • ETH Zurich

Registry information

Acronym: GLACIER

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 14, 2019
Registry last updated
Jan 25, 2022

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.