Back to resultsCold Induced Futile Cycles In White Adipose Tissue (Metabol)
Primary Purpose
Metabolism Disorder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
External cooling
FDG PET/CT
13C-Glucose injection
Sponsored by
About this trial
This is an interventional basic science trial for Metabolism Disorder focused on measuring Glucose metablism, futil cycles, FDG PET/CT
Eligibility Criteria
Inclusion Criteria:
- Informed Consent as documented by signature
- 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:
- any clinically relevant history or the presence of e.g. respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, metabolic disease, etc.
- 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
Sites / Locations
- Kantonsspitla Baden
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Biopsy without cold induction
Biopsy with cold induction
Arm Description
Participants will undergo a fat biopsy after the first scan, without cooling
Participants will undergo a fat biopsy after the second scan, with cooling
Outcomes
Primary Outcome Measures
Comparison of FDG influx into WAT
Comparing the 18F-FDG influx rate (Ki) into the white adipose tissue with and without cold stimulation (intra-individually).
Secondary Outcome Measures
Quantification of 13C-Glucose metabolites in fat
Comparing the 13C-Glucose accumulation in white adipose tissue between Group A (without cold) and B (with cold) stimulation
Quantification of 13C-Glucose metabolites in blood
13C-Lactate concentration in blood samples between Group A (without cold) and B (with cold) stimulation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04614116
Brief Title
Cold Induced Futile Cycles In White Adipose Tissue
Acronym
Metabol
Official Title
Cold Induced Futile Cycles In White Adipose Tissue: Quantification And Characterization With Dual Glucose Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
March 29, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Baden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigation of futile cycles in white adipose tissue under cold conditions for thermogenesis using two substitutes for glucose metabolism (18F-FDG and 13C-Glucose).
Detailed Description
Thermogenesis is defined as a process, which generates heat by the depletion of energy-rich molecules. Evolutionary, it is an essential process that allows the survival at lower temperatures. Since the discovery of brown adipose tissue (BAT) it is believed that this part of the adipose tissue can dissipate energy for heat thanks to the uncoupling protein 1 (UCP1). Since energy expenditure is increased as a consequence of thermogenesis, pharmacological induction of this pathway presents an interesting therapeutic target to counter obesity. However, recent investigations indicate that white adipose tissue (WAT) is much more versatile and probably essentially indispensable for thermogenesis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolism Disorder
Keywords
Glucose metablism, futil cycles, FDG PET/CT
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non blinded, randomised, open label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biopsy without cold induction
Arm Type
Other
Arm Description
Participants will undergo a fat biopsy after the first scan, without cooling
Arm Title
Biopsy with cold induction
Arm Type
Other
Arm Description
Participants will undergo a fat biopsy after the second scan, with cooling
Intervention Type
Other
Intervention Name(s)
External cooling
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
FDG PET/CT
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
13C-Glucose injection
Intervention Description
0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection
Primary Outcome Measure Information:
Title
Comparison of FDG influx into WAT
Description
Comparing the 18F-FDG influx rate (Ki) into the white adipose tissue with and without cold stimulation (intra-individually).
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Quantification of 13C-Glucose metabolites in fat
Description
Comparing the 13C-Glucose accumulation in white adipose tissue between Group A (without cold) and B (with cold) stimulation
Time Frame
2 days
Title
Quantification of 13C-Glucose metabolites in blood
Description
13C-Lactate concentration in blood samples between Group A (without cold) and B (with cold) stimulation.
Time Frame
2 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Only male volunteers
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Informed Consent as documented by signature
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:
any clinically relevant history or the presence of e.g. respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, metabolic disease, etc.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irene A. Burger, MD
Organizational Affiliation
Kantonsspital Baden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspitla Baden
City
Baden
State/Province
Aargau
ZIP/Postal Code
5404
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cold Induced Futile Cycles In White Adipose Tissue
We'll reach out to this number within 24 hrs