Cold-induced Brown Fat Activation and Hepatic Steatosis

NCT03811236 | Recruiting

• 1 other identifier: 1911/2017
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• Hepatic lipid content (%)

  Magnetic resonance imaging-proton density fat fraction

  Six weeks

Secondary Outcomes (5)

• Brown adipose tissue volume (ml) / activity (SUVmean)

  Six weeks

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

  Six weeks

• Cold-induced non-shivering thermogenesis (%)

  Six weeks

• Body fat mass (kg)

  Six weeks

• Insulin sensitivity

  Six weeks

Study Arms (2)

Cold exposure

EXPERIMENTAL

Other: Cold exposure

Room temperature

NO INTERVENTION

Interventions

Cold exposure OTHER

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

Cold exposure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Florian Kiefer, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florian Kiefer, MD, PhD

CONTACT

+43140400; florian.kiefer@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 18, 2019
• First Posted: January 22, 2019
• Study Start: January 21, 2019
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)