Vitamin A in Brown Fat Activity

NCT ID: NCT02381483

Last Updated: 2018-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-04-15

Brief Summary

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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.

Detailed Description

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Conditions

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Brown Adipose Tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Lean

Cold exposure

Group Type EXPERIMENTAL

Cold exposure

Intervention Type OTHER

Obese

Cold exposure

Group Type EXPERIMENTAL

Cold exposure

Intervention Type OTHER

Interventions

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Cold exposure

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Dr. Florian Kiefer

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Florian Kiefer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 32343312 (View on PubMed)

Other Identifiers

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1032/2013

Identifier Type: -

Identifier Source: org_study_id

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