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NCT Number: NCT03811236

Cold-induced Brown Fat Activation and Hepatic Steatosis

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Florian Kiefer, MD, PhD

CONTACT

[email protected]

+43140400 ext. 43120

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Cold exposure

Other

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

Primary outcomes

  1. Hepatic lipid content (%)

    Time frame: Six weeks

    Magnetic resonance imaging-proton density fat fraction

Secondary outcomes

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

    Time frame: Six weeks

    18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging

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

    Time frame: Six weeks

    Indirect calorimetry

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

    Time frame: Six weeks

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

  4. Body fat mass (kg)

    Time frame: Six weeks

    Air displacement plethysmography

  5. Insulin sensitivity

    Time frame: Six weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Florian Kiefer, MD, PhD

CONTACT

[email protected]

+43140400 ext. 43120

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2019
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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