Cold-induced Brown Fat Activation and Hepatic Steatosis

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Cold-induced Brown Fat Activation and Hepatic Steatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03811236
• Other study ID #: 1911/2017
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Medical University of Vienna
• Contact: Florian Kiefer, MD, PhD
• Phone: +43140400
• Email: florian.kiefer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Other:
• Cold exposure
Two hours of mild cold exposure using a water-perfused vest

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic lipid content (%)	Magnetic resonance imaging-proton density fat fraction	Six weeks
Secondary	Brown adipose tissue volume (ml) / activity (SUVmean)	18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging	Six weeks
Secondary	Basal metabolic rate (kcal/day/kg fat-free body mass)	Indirect calorimetry	Six weeks
Secondary	Cold-induced non-shivering thermogenesis (%)	Indirect calorimetry: percentage increase in basal metabolic rate before and after cold exposure	Six weeks
Secondary	Body fat mass (kg)	Air displacement plethysmography	Six weeks
Secondary	Insulin sensitivity	"Matsuda Index" for 2 hour standard oral glucose tolerance test	Six weeks