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出境医 / 临床实验 / Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate (GLACIER)
Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate (GLACIER)
Study Description
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.
Study Design
| 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 : | December 1, 2021 |
| Estimated Study Completion Date : | December 1, 2021 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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 :
- 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
- 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
- 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
- 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
Eligibility Criteria
| 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
Contacts and Locations
Locations
| Switzerland | |
| University Hospital Basel, Department of Endocrinology | |
| Basel, BS, Switzerland, 4031 | |
Sponsors and Collaborators
University Hospital, Basel, Switzerland
ETH Zurich
Investigators
| Study Director: | Matthias Matthias, PD Dr. med | Klinik Endokrinologie, Diabetes und Metabolismus |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 2, 2019 | ||||
| First Posted Date | May 14, 2019 | ||||
| Last Update Posted Date | May 5, 2021 | ||||
| Actual Study Start Date | June 1, 2019 | ||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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)
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate | ||||
| Official Title | Glucocorticoid Long-term Administration: Effect on Cold Induced Energy Expenditure and Resting Metabolic Rate | ||||
| 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. | ||||
| 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. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description:
Serum and plasma Optional biopsy of supraclavicular BAT
|
||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients will be recruited via the outpatient clinics (endocrinology, rheumathology, ophthalmology, gastroenterology etc.) of the Basel University Hospital. | ||||
| Condition | Thermoregulation Impairment | ||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Estimated Enrollment |
24 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 1, 2021 | ||||
| Estimated Primary Completion Date | December 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 75 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Switzerland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03949361 | ||||
| Other Study ID Numbers | EKNZ 2017-01742 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | University Hospital, Basel, Switzerland | ||||
| Study Sponsor | University Hospital, Basel, Switzerland | ||||
| Collaborators | ETH Zurich | ||||
| Investigators |
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| PRS Account | University Hospital, Basel, Switzerland | ||||
| Verification Date | May 2021 | ||||
