Metabolism DisorderMetabolNCT04614116
Cold Induced Futile Cycles In White Adipose Tissue
A study testing External cooling, FDG PET/CT and 13C-Glucose injection in people with Metabolism Disorder, run by Kantonsspital Baden at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolism Disorder
- What is being tested?
- External cooling, FDG PET/CT and 13C-Glucose injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jun 2021to 29 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Induced Futile Cycles In White Adipose Tissue: Quantification And Characterization With Dual Glucose Analysis
Investigation of futile cycles in white adipose tissue under cold conditions for thermogenesis using two substitutes for glucose metabolism (18F-FDG and 13C-Glucose).
Read the 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.
- Conditions
- Metabolism Disorder
- Being tested
- External cooling, FDG PET/CT, 13C-Glucose injection
- Keywords
- Glucose metablism, futil cycles, FDG PET/CT
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External coolingOther
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/CTDiagnostic test
- 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 injectionDiagnostic test
0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection
| Study group | Role | What they receive |
|---|---|---|
| Biopsy without cold induction | Other | Participants will undergo a fat biopsy after the first scan, without cooling Receives: 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 Receives: Other: External cooling; Diagnostic Test: FDG PET/CT; Diagnostic Test: 13C-Glucose injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 days
Secondary outcomes (2)
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
Measured: 2 days
Quantification of 13C-Glucose metabolites in blood
13C-Lactate concentration in blood samples between Group A (without cold) and B (with cold) stimulation.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start15 Jun 2021
- Primary completion17 Feb 2022
- Study completion29 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolism DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non blinded, randomised, open label
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene A. Burger, Kantonsspital Baden
- Investigators
- Irene A. Burger, MD, Principal investigator, Kantonsspital Baden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614116
- Sponsor's protocol ID
- Cold exposure of WAT
- Acronym
- Metabol
- Status last verified
- Mar 2022
- First submitted
- 28 Oct 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Induced Futile Cycles In White Adipose Tissue: Quantification And Characterization With Dual Glucose Analysis
- ClinicalTrials.gov ID
- NCT04614116
- Acronym / sponsor ID
- Metabol / Cold exposure of WAT
- Conditions
- Metabolism Disorder
- Keywords
- Glucose metablism, futil cycles, FDG PET/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non blinded, randomised, open label
| Arm | Type | Receives |
|---|---|---|
| Biopsy without cold induction | Other | Diagnostic Test: FDG PET/CT, Diagnostic Test: 13C-Glucose injectionParticipants will undergo a fat biopsy after the first scan, without cooling |
| Biopsy with cold induction | Other | Other: External cooling, Diagnostic Test: FDG PET/CT, Diagnostic Test: 13C-Glucose injectionParticipants will undergo a fat biopsy after the second scan, with cooling |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External coolingwater-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. | Other | Biopsy with cold induction |
| FDG PET/CTo 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 | Biopsy with cold induction, Biopsy without cold induction |
| 13C-Glucose injection0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection | Diagnostic test | Biopsy with cold induction, Biopsy without cold induction |
Primary outcome
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).
2 secondary outcomes
Quantification of 13C-Glucose metabolites in fat
Time frame: 2 days
Quantification of 13C-Glucose metabolites in blood
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irene A. Burger, MD principal investigator
Kantonsspital Baden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External cooling, FDG PET/CT and 13C-Glucose injection in people with Metabolism Disorder, run by Kantonsspital Baden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of FDG influx into WAT (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.