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Cold-induced Brown Fat Activation and Hepatic Steatosis

Sponsor
Medical University of Vienna (Other)
Overall Status
Suspended
CT.gov ID
NCT03811236
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
70.3
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cold exposure
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Cold-induced Brown Fat Activation and Hepatic Steatosis
Actual Study Start Date :
Jan 21, 2019
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cold exposure

Other: Cold exposure
Two hours of mild cold exposure using a water-perfused vest
No Intervention: Room temperature

Outcome Measures

Primary Outcome Measures

  1. Hepatic lipid content (%) [Six weeks]

    Magnetic resonance imaging-proton density fat fraction

Secondary Outcome Measures

  1. Brown adipose tissue volume (ml) / activity (SUVmean) [Six weeks]

    18-fluorodeoxyglucose positron emission tomography/ magnetic resonance imaging

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

    Indirect calorimetry

  3. Cold-induced non-shivering thermogenesis (%) [Six weeks]

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

  4. Body fat mass (kg) [Six weeks]

    Air displacement plethysmography

  5. Insulin sensitivity [Six weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Vienna Vienna Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

  • Principal Investigator: Florian Kiefer, MD, PhD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Florian Kiefer, Associate Professor of Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT03811236
Other Study ID Numbers:
  • 1911/2017
First Posted:
Jan 22, 2019
Last Update Posted:
Apr 13, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Apr 13, 2022