Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949361
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : June 17, 2020
Sponsor:
Collaborator:
ETH Zurich
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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.

Condition or disease Intervention/treatment
Thermoregulation Impairment Diagnostic Test: Indirect calorimetry Diagnostic Test: Skin Temperature Diagnostic Test: Dual energy X-ray Absorptiometry (DXA) Diagnostic Test: Blood Sampling Diagnostic Test: FDG-PET Diagnostic Test: Capillary glucose Diagnostic Test: Biopsy of supraclavicular adipose tissue (optional)

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Group/Cohort Intervention/treatment
Patients starting glucocorticoids
Patients starting a glucocorticoid therapy measuring primary and secondary endpoints before and after at least 4 weeks of treatment.
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

Patients stopping glucocorticoids
Patients stopping a glucocorticoid therapy measuring primary and secondary endpoints before weaning off glucocorticoids and after a period of at least 3 months.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Serum and plasma Optional biopsy of supraclavicular BAT


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients will be recruited via the outpatient clinics (endocrinology, rheumathology, ophthalmology, gastroenterology etc.) of the Basel University Hospital.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949361


Contacts
Layout table for location contacts
Contact: Matthias Matthias, PD Dr. med 0041 61 556 56 54 Matthias.Betz@usb.ch
Contact: Claudia Maushart, Dr. med claudia.maushart@usb.ch

Locations
Layout table for location information
Switzerland
University Hospital Basel, Department of Endocrinology Recruiting
Basel, BS, Switzerland, 4031
Contact: Matthias J Betz, MD    0041 61 265 5078    matthias.betz@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
ETH Zurich
Investigators
Layout table for investigator information
Study Director: Matthias Matthias, PD Dr. med Klinik Endokrinologie, Diabetes und Metabolismus
Layout table for additonal information
Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03949361    
Other Study ID Numbers: EKNZ 2017-01742
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Glucocorticoids
Brown Adipose tissue
Cold Induced Thermogenesis
Resting Metabolic Rate