NCT03168009

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

Enrollment Period

4.6 years

First QC Date

May 23, 2017

Last Update Submit

April 9, 2022

Conditions

Keywords

BATBariatric SurgeryEnergy Metabolism

Outcome Measures

Primary Outcomes (1)

  • Changes in BAT activity after bariatric surgery

    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 Outcomes (2)

  • Bariatric surgery-induced changes in gut microbiota, bile acid composition and other circulating factors

    4 years

  • Association between changes in BAT activity, transcriptional BAT markers and alterations in the gut microbiota profile or bile acid composition

    4 years

Study Arms (1)

Bariatric Surgery

EXPERIMENTAL

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

Interventions

Patients will undergo bariatric surgery as routinely scheduled. The type of bariatric procedure will be suggested by the surgeon based on clinical considerations.

Bariatric Surgery

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

  • Herz CT, Kulterer OC, Prager M, Marculescu R, Prager G, Kautzky-Willer A, Hacker M, Trajanoski S, Kofeler HC, Galle B, Haug AR, Berry D, Kiefer FW. Bariatric surgery promotes recruitment of brown fat linked to alterations in the gut microbiota. Eur J Endocrinol. 2025 Apr 30;192(5):603-611. doi: 10.1093/ejendo/lvaf081.

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Florian Kiefer, MD,PHD

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 23, 2017

First Posted

May 30, 2017

Study Start

May 24, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations