Cold Induced Futile Cycles In White Adipose Tissue

NCT04614116 | Completed DMC

• 1 other identifier: Cold exposure of WAT
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Metabolism Disorder

Keywords

Glucose metablism; futil cycles; FDG PET/CT

Outcome Measures

Primary Outcomes (1)

• 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).

  2 days

Secondary Outcomes (2)

• Quantification of 13C-Glucose metabolites in fat

  2 days

• Quantification of 13C-Glucose metabolites in blood

  2 days

Study Arms (2)

Biopsy without cold induction

OTHER

Participants will undergo a fat biopsy after the first scan, without cooling

Diagnostic Test: FDG PET/CT; Diagnostic Test: 13C-Glucose injection

Biopsy with cold induction

OTHER

Participants will undergo a fat biopsy after the second scan, with cooling

Other: External cooling; Diagnostic Test: FDG PET/CT; Diagnostic Test: 13C-Glucose injection

Interventions

External cooling OTHER

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.

Biopsy with cold induction

FDG PET/CT DIAGNOSTIC_TEST

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.

Biopsy with cold induction; Biopsy without cold induction

13C-Glucose injection DIAGNOSTIC_TEST

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

Biopsy with cold induction; Biopsy without cold induction

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only male volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kantonsspital Baden: lead

Study Sites (1)

Kantonsspitla Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• Irene A. Burger, MD

  Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of clinic

Model Details: Non blinded, randomised, open label

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: June 15, 2021
• Primary Completion: February 17, 2022
• Study Completion: March 29, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)