Non-Alcoholic Fatty Liver DiseaseNCT03811236
Cold-induced Brown Fat Activation and Hepatic Steatosis
A study testing Cold exposure in people with Non-Alcoholic Fatty Liver Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
In the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as well as higher activity thereof are associated with a favourable metabolic phenotype. Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity of BAT which significantly increased in size and… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Cold exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- 21 Jan 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- body mass index 28 - 40 kg/m^2
- hepatic lipid content > 10 %
Who cannot join
- endocrine disease, except treated hypo-/hyperthyroidism and hypertriglyceridemia (<500 mg/dl) and untreated type II diabetes mellitus (fasting glucose < 140 mg/dl)
- use of beta-blockers, alpha-blockers and rilmenidine
- chronic kidney disease
- inflammatory bowel disease
- active malignant disease
- autoimmune disease
Show all 16Show fewer
- chronic alcohol abuse or alcohol consumption greater than 30g/d for men or 20 g/d for women
- transferrin saturation > 40%
- serum alpha-1 antitrypsin < 90 mg/dl
- serum ceruloplasmin < 20 mg/dl
- positive serology for autoimmune hepatitis
- positive hepatitis serology
- liver cirrhosis
- portal hypertension
- pregnancy
- contraindications for magnetic resonance imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Florian Kiefer, MD, PhD, +43140400 ext. 43120, florian.kiefer@meduniwien.ac.at
About this study
In the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as well as higher activity thereof are associated with a favourable metabolic phenotype. Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity of BAT which significantly increased in size and activity during these studies. These changes were accompanied by improvements in body fat mass as well as insulin sensitivity. Non-alcoholic fatty liver disease (NAFLD) is estimated to advance to the primary cause of liver cirrhosis and hepatocellular carcinoma in the following years. Besides predisposing genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the main factors contributing to this excessive hepatic lipid accumulation.
The aim of this study is to investigate whether BAT recruitment via cold-acclimation results in decreased hepatic lipid content in overweight/obese patients with NAFLD.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Cold exposure
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold exposureOther
Two hours of mild cold exposure using a water-perfused vest
| Study group | Role | What they receive |
|---|---|---|
| Cold exposure | Experimental | Not described Receives: Other: Cold exposure |
| Room temperature | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic lipid content (%)
Magnetic resonance imaging-proton density fat fraction
Measured: Six weeks
Secondary outcomes (5)
Brown adipose tissue volume (ml) / activity (SUVmean)
18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging
Measured: Six weeks
Basal metabolic rate (kcal/day/kg fat-free body mass)
Indirect calorimetry
Measured: Six weeks
Cold-induced non-shivering thermogenesis (%)
Indirect calorimetry: percentage increase in basal metabolic rate before and after cold exposure
Measured: Six weeks
Body fat mass (kg)
Air displacement plethysmography
Measured: Six weeks
Insulin sensitivity
"Matsuda Index" for 2 hour standard oral glucose tolerance test
Measured: Six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start21 Jan 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Florian Kiefer, Medical University of Vienna
- Investigators
- Florian Kiefer, MD, PhD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03811236
- Sponsor's protocol ID
- 1911/2017
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold-induced Brown Fat Activation and Hepatic Steatosis
- ClinicalTrials.gov ID
- NCT03811236
- Acronym / sponsor ID
- 1911/2017
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jan 2019 (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.
In the recent years, research on brown adipose tissue (BAT) revealed that larger amounts as well as higher activity thereof are associated with a favourable metabolic phenotype. Longitudinal studies which applied recurrent cooling sessions demonstrated a high plasticity of BAT which significantly increased in size and activity during these studies. These changes were accompanied by improvements in body fat mass as well as insulin sensitivity. Non-alcoholic fatty liver disease (NAFLD) is estimated to advance to the primary cause of liver cirrhosis and hepatocellular carcinoma in the following years. Besides predisposing genetic and possibly nutritional factors, the insulin resistance syndrome and obesity are the main factors contributing to this excessive hepatic lipid accumulation.
The aim of this study is to investigate whether BAT recruitment via cold-acclimation results in decreased hepatic lipid content in overweight/obese patients with NAFLD.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold exposure | Experimental | Other: Cold exposure |
| Room temperature | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- body mass index 28 - 40 kg/m^2
- hepatic lipid content > 10 %
Key exclusion criteria (16 listed)
- endocrine disease, except treated hypo-/hyperthyroidism and hypertriglyceridemia (<500 mg/dl) and untreated type II diabetes mellitus (fasting glucose < 140 mg/dl)
- use of beta-blockers, alpha-blockers and rilmenidine
- chronic kidney disease
- inflammatory bowel disease
- active malignant disease
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 |
|---|---|---|
| Cold exposureTwo hours of mild cold exposure using a water-perfused vest | Other | Cold exposure |
Primary outcome
Hepatic lipid content (%)
Time frame: Six weeks
Magnetic resonance imaging-proton density fat fraction
5 secondary outcomes
Brown adipose tissue volume (ml) / activity (SUVmean)
Time frame: Six weeks
Basal metabolic rate (kcal/day/kg fat-free body mass)
Time frame: Six weeks
Cold-induced non-shivering thermogenesis (%)
Time frame: Six weeks
Body fat mass (kg)
Time frame: Six weeks
Insulin sensitivity
Time frame: Six weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- 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.
Florian Kiefer, MD, PhD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold exposure in people with Non-Alcoholic Fatty Liver Disease, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 13 Mar 2024. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florian Kiefer, MD, PhD (+43140400 ext. 43120, florian.kiefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic lipid content (%) (time frame: Six weeks). 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 13 Mar 2024.