Vitamin A in Brown Fat Activity

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02381483
Collaborator
(none)
66
1
2
50.4
1.3

Study Details

Study Description

Brief Summary

Vitamin A metabolites (retinoids) have shown to activate brown fat function in preclinical studies, however the role of retinoids in human brown fat physiology and energy metabolism remains elusive. This study aims to identify a possible association between retinoid metabolism, brown fat activity, and energy expenditure in lean and obese subjects by using FDG-PET-CT, PET-MR Scans and indirect calorimetry. Additionally we will analyze the genetic profile of white and brown neck fat biopsies at room temperature and cold conditions in a subset of the study participants. More detailed molecular studies (involving other potential browning markers) will also be performed in adipocytes derived from human SVC.

The optimal duration of cold exposure will be determined in a pilot study. Therefore subjects will be repeatedly exposed to cold and circulating retinoid levels and other plasma parameters will be measured at various time points.

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

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Role of Vitamin A in Brown Fat Activity and Energy Metabolism
Study Start Date :
Feb 1, 2014
Actual Primary Completion Date :
Apr 15, 2018
Actual Study Completion Date :
Apr 15, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lean

Cold exposure

Other: Cold exposure

Experimental: Obese

Cold exposure

Other: Cold exposure

Outcome Measures

Primary Outcome Measures

  1. Correlation between retinol/retinol-binding protein concentrations and cold-induced brown fat acitivity [6 years]

    A possible association between serum retinol and retinol-binding protein concentrations and cold-induced brown fat activity in lean and obese subjects, respectively, will be analyzed.

Secondary Outcome Measures

  1. Analyses of potential BAT or browning markers in humans [6 years]

  2. Association between BAT activity and energy expenditure [6 years]

  3. Identification of new factors related to brown fat function [6 years]

    This is a very exploratory aim that involves a number of molecular tests. Therefore no single outcome measure can be defined here. Briefly, we will perform mRNA and miRNA analyses from BAT biopsies and plasma before and after cold exposure to identify new factors related to BAT function. Potential candidates will be tested in loss- or gain-of-function models in isolated human and/or murine adipocytes. In addition, the thermogenic effects of commercially available peptides, hormones, lipids, or steroid acids, will be tested in primary adipocytes.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Age 20 - 45 years.

  • Body mass index (BMI) 18.5 - 24.9 kg/m2 (lean) or 30.0 - 38.0 kg/m2 (obese)

Exclusion Criteria:
  • Endocrine (except hyperlipidemia), cardiovascular (except hypertension), liver, kidney, inflammatory bowel, rheumatic, oncologic disease or any other chronic condition.

  • Medication for any of the above mentioned conditions.

  • Pregnancy

  • Metallic implants that are not MRI compatible

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, MD, PhD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02381483
Other Study ID Numbers:
  • 1032/2013
First Posted:
Mar 6, 2015
Last Update Posted:
Aug 20, 2018
Last Verified:
Aug 1, 2018

Study Results

No Results Posted as of Aug 20, 2018