Vitamin A in Brown Fat Activity

NCT02381483 | Completed DMC

• 1 other identifier: 1032/2013
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Brown Adipose Tissue

Outcome Measures

Primary Outcomes (1)

• Correlation between retinol/retinol-binding protein concentrations and cold-induced brown fat acitivity

  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.

  6 years

Secondary Outcomes (3)

• Analyses of potential BAT or browning markers in humans

  6 years

• Association between BAT activity and energy expenditure

  6 years

• Identification of new factors related to brown fat function

  6 years

Study Arms (2)

Lean

EXPERIMENTAL

Cold exposure

Other: Cold exposure

Obese

EXPERIMENTAL

Cold exposure

Other: Cold exposure

Interventions

Cold exposure OTHER

Lean; Obese

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20 - 45 years.
• Body mass index (BMI) 18.5 - 24.9 kg/m2 (lean) or 30.0 - 38.0 kg/m2 (obese)

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Kulterer OC, Niederstaetter L, Herz CT, Haug AR, Bileck A, Pils D, Kautzky-Willer A, Gerner C, Kiefer FW. The Presence of Active Brown Adipose Tissue Determines Cold-Induced Energy Expenditure and Oxylipin Profiles in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa183. doi: 10.1210/clinem/dgaa183.

  PMID: 32343312 DERIVED

Study Officials

• Florian Kiefer, MD, PhD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 14, 2015
• First Posted: March 6, 2015
• Study Start: February 1, 2014
• Primary Completion: April 15, 2018
• Study Completion: April 15, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

AU (1)