Brown Fat Activity and Bariatric Surgery

April 9, 2022 updated by: Dr. Florian Kiefer, Medical University of Vienna

The Role of Alternatively Activated Brown Fat in Bariatric Surgery-mediated Metabolic Improvements

The mechanisms of bariatric surgery-induced weight loss go beyond reductions in calorie intake and may involve several other pathways. Recently, brown adipose tissue (BAT) has been added as another potential player. Activation of BAT results in enhanced energy expenditure and promotes weight loss. Here, the investigators will study the effects of bariatric surgery on BAT function by PET/CT studies and molecular analyses of adipose biopsies. The investigators will explore different pathways that may affect BAT activation in this patient population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20 - 50 years
  • Body mass index (BMI) 35 - 55kg/m2

Exclusion Criteria:

  • Endocrine disease (except hyperlipidemia and substituted hypothyroidism or type 2 diabetes with fasting glucose concentrations <120mg/dl), kidney disease, inflammatory bowel disease, autoimmune or rheumatologic diseases that require immunosuppressive treatment, active oncologic disease, heart failure.
  • Medication for any of the above mentioned conditions.
  • Antibiotic treatment in the past three months
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bariatric Surgery
Patients will undergo either Omega Loop Gastric Bypass or Sleeve Gastrectomy. The decision which type of surgery will be performed, will by made by the surgeon and the patient based on clinical considerations and the patient's wishes.
Procedure: Bariatric Surgery
Patients will undergo bariatric surgery as routinely scheduled. The type of bariatric procedure will be suggested by the surgeon based on clinical considerations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in BAT activity after bariatric surgery
Time Frame: 4 years
The primary outcome of this study is to determine whether Omega Loop Gastric Bypass and Sleeve Gastrectomy result in increased BAT activity
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bariatric surgery-induced changes in gut microbiota, bile acid composition and other circulating factors
Time Frame: 4 years
Any pre-versus postsurgical changes of the gut microbiota or bile acid composition or other circulating factors will be evaluated.
4 years
Association between changes in BAT activity, transcriptional BAT markers and alterations in the gut microbiota profile or bile acid composition
Time Frame: 4 years
Linear regression analyses will be performed to determine any association between BAT activity or molecular signature and changes in the gut microbiota or bile acids
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2017

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 24, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1071/2017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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