Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2021-06-15
2022-03-29
Brief Summary
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Detailed Description
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To investigate the mechanism of this futile cycle in WAT we plan to investigate the glucose metabolism in 24 healthy volunteers with 2 exams (one with and one without external cooling) with two substitutes for glucose. We will use 18F-FDG to quantify the glucose influx into WAT using dynamic PET/CT scans and 13C-Glucose to analyze the downstream metabolites.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Biopsy without cold induction
Participants will undergo a fat biopsy after the first scan, without cooling
FDG PET/CT
o 75 MBq 18F-FDG will be injected through the intravenous line on the scanner manually (bolus injection) with a simultaneous start of dynamic FDG-PET/CT scan for 45 minutes and a partial body scan from head to the abdomen after 45 minutes. Total scan time 60 minutes.
13C-Glucose injection
0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection
Biopsy with cold induction
Participants will undergo a fat biopsy after the second scan, with cooling
External cooling
water-circulating cooling/warming sleeves connected to a medical cooling device (Hilotherm Clinic®, Hilotherm GmbH, Germany) will be placed around the subject's abdomen and lower back. Initially the temperature of the water will be set to 25°C. A mild cold stimulus will be applied by reducing the temperature of the circulating water by approximately 1°C every 2 minutes to a minimum of 10°C.
FDG PET/CT
o 75 MBq 18F-FDG will be injected through the intravenous line on the scanner manually (bolus injection) with a simultaneous start of dynamic FDG-PET/CT scan for 45 minutes and a partial body scan from head to the abdomen after 45 minutes. Total scan time 60 minutes.
13C-Glucose injection
0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection
Interventions
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External cooling
water-circulating cooling/warming sleeves connected to a medical cooling device (Hilotherm Clinic®, Hilotherm GmbH, Germany) will be placed around the subject's abdomen and lower back. Initially the temperature of the water will be set to 25°C. A mild cold stimulus will be applied by reducing the temperature of the circulating water by approximately 1°C every 2 minutes to a minimum of 10°C.
FDG PET/CT
o 75 MBq 18F-FDG will be injected through the intravenous line on the scanner manually (bolus injection) with a simultaneous start of dynamic FDG-PET/CT scan for 45 minutes and a partial body scan from head to the abdomen after 45 minutes. Total scan time 60 minutes.
13C-Glucose injection
0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection
Eligibility Criteria
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Inclusion Criteria
* Healthy participants, as determined by screening assessments and Principal Investigator's judgment
* Health status is defined by the absence of evidence of any active or chronic disease following a medical and surgical history, basic physical examination and blood test
Exclusion Criteria
* Intake of the following medications: Insulin, oral antidiabetic drugs, GLP-1-agonists, Corticosteroids, Sympathomimetic and Sympatholytic drug, Beta-Blocker, Statins.
* BMI \> 35 kg/m2
* Resting pulse rate \> 70 bpm, resting blood pressure \> 130/90 mmHg.
* Serum creatinine \> 145 µmol/L
* ASAT\> 75 U/L and ALAT \> 75 U/L
* γ GT \> 100 UI/L and total bilirubin \> 30 µmol/l
* Glucose \> 7.1 mmol/L
* HbA1c \> 46 mmol/mol (\>6.4%)
* Intake of anticoagulants or inhibitors of platelet aggregation (e.g. Aspirin, clopidogrel).
* Known tendency to form keloids (hypertrophic scar tissue)
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Participation in another study involving ionizing radiation in the same year
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
18 Years
45 Years
MALE
Yes
Sponsors
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Kantonsspital Baden
OTHER
Responsible Party
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Irene A. Burger
Head of clinic
Principal Investigators
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Irene A. Burger, MD
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Baden
Locations
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Kantonsspitla Baden
Baden, Canton of Aargau, Switzerland
Countries
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Other Identifiers
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Cold exposure of WAT
Identifier Type: -
Identifier Source: org_study_id
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