Cold Induced Futile Cycles In White Adipose Tissue

NCT ID: NCT04614116

Last Updated: 2022-03-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-03-29

Brief Summary

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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

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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.

Conditions

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Metabolism Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Non blinded, randomised, open label
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Biopsy without cold induction

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

Group Type OTHER

FDG PET/CT

Intervention Type 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.

13C-Glucose injection

Intervention Type DIAGNOSTIC_TEST

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

Group Type OTHER

External cooling

Intervention Type 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.

FDG PET/CT

Intervention Type 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.

13C-Glucose injection

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type OTHER

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.

Intervention Type DIAGNOSTIC_TEST

13C-Glucose injection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kantonsspital Baden

OTHER

Sponsor Role lead

Responsible Party

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Irene A. Burger

Head of clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Switzerland

Other Identifiers

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Cold exposure of WAT

Identifier Type: -

Identifier Source: org_study_id

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