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Cold Induced Futile Cycles In White Adipose Tissue (Metabol)

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ClinicalTrials.gov Identifier: NCT04614116
Recruitment Status : Recruiting
First Posted : November 3, 2020
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Irene A. Burger, Kantonsspital Baden

Study Description
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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).

Condition or disease Intervention/treatment Phase
Metabolism Disorder Other: External cooling Diagnostic Test: FDG PET/CT Diagnostic Test: 13C-Glucose injection Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non blinded, randomised, open label
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Cold Induced Futile Cycles In White Adipose Tissue: Quantification And Characterization With Dual Glucose Analysis
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Biopsy without cold induction
Participants will undergo a fat biopsy after the first scan, without cooling
 Diagnostic Test: 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.

Diagnostic Test: 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
 Other: 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.

Diagnostic Test: 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.

Diagnostic Test: 13C-Glucose injection
0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of FDG influx into WAT [ Time Frame: 2 days ]
    Comparing the 18F-FDG influx rate (Ki) into the white adipose tissue with and without cold stimulation (intra-individually).


Secondary Outcome Measures :
  1. Quantification of 13C-Glucose metabolites in fat [ Time Frame: 2 days ]
    Comparing the 13C-Glucose accumulation in white adipose tissue between Group A (without cold) and B (with cold) stimulation

  2. Quantification of 13C-Glucose metabolites in blood [ Time Frame: 2 days ]
    13C-Lactate concentration in blood samples between Group A (without cold) and B (with cold) stimulation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male volunteers
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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): NCT04614116


Contacts
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Contact: Irene A Burger, MD 056 486 38 71 ext +41 irene.burger@ksb.ch
Contact: Riccardo Laudicella, MD 056 486 38 80 ext +41 riccardo.laudicella@ksb.ch

Locations
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Switzerland
Kantonsspitla Baden Recruiting
Baden, Aargau, Switzerland, 5404
Contact: Irene A Burger    +41564863871    irene.burger@ksb.ch   
Contact: Claudia Ladwig    +41564863873    claudia.ladwig@ksb.ch   
Sponsors and Collaborators
Kantonsspital Baden
Investigators
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Principal Investigator: Irene A. Burger, MD Kantonsspital Baden
More Information
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Responsible Party: Irene A. Burger, Head of clinic, Kantonsspital Baden
ClinicalTrials.gov Identifier: NCT04614116    
Other Study ID Numbers: Cold exposure of WAT
First Posted: November 3, 2020    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irene A. Burger, Kantonsspital Baden:
Glucose metablism
futil cycles
FDG PET/CT
Additional relevant MeSH terms:
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Metabolic Diseases