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RecruitingNCT03811236Updated Mar 13, 2024

Cold-induced Brown Fat Activation and Hepatic Steatosis

An interventional study of Cold exposure in Non-Alcoholic Fatty Liver Disease, sponsored by Medical University of Vienna. Recruiting at 1 site in Austria. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2019; still recruiting 7 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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 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.

02

Conditions studied

03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's planned enrollment of 26 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • body mass index 28 - 40 kg/m\^2
  • hepatic lipid content > 10 %

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Cold exposure

    Other: Cold exposure

  • No intervention
    Room temperature

Interventions

  • OtherCold exposure

    Two hours of mild cold exposure using a water-perfused vest

06

What researchers measure

Primary outcomes

  1. Hepatic lipid content (%)

    Magnetic resonance imaging-proton density fat fraction

    Time frame: Six weeks

Secondary outcomes

  1. Brown adipose tissue volume (ml) / activity (SUVmean)

    18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging

    Time frame: Six weeks

  2. Basal metabolic rate (kcal/day/kg fat-free body mass)

    Indirect calorimetry

    Time frame: Six weeks

  3. Cold-induced non-shivering thermogenesis (%)

    Indirect calorimetry: percentage increase in basal metabolic rate before and after cold exposure

    Time frame: Six weeks

  4. Body fat mass (kg)

    Air displacement plethysmography

    Time frame: Six weeks

  5. Insulin sensitivity

    "Matsuda Index" for 2 hour standard oral glucose tolerance test

    Time frame: Six weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03811236
Lead sponsor
Medical University of Vienna
Responsible party
Dr. Florian Kiefer (Associate Professor of Medicine, Medical University of Vienna) — Principal investigator
First posted
Jan 22, 2019
Start date
Jan 21, 2019
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Mar 13, 2024

Study contacts

Florian Kiefer, MD, PhD
Contact
florian.kiefer@meduniwien.ac.at
+43140400 ext. 43120
Florian Kiefer, MD, PhD
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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