Brown Fat Activity and Bariatric Surgery

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Procedure: Bariatric Surgery

• Registration Number: NCT03168009
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-23
• Study Start: 2017-05-24
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bariatric Surgery	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Bariatric surgery-induced changes in gut microbiota, bile acid composition and other circulating factors	4 years	Any pre-versus postsurgical changes of the gut microbiota or bile acid composition or other circulating factors will be evaluated.
Association between changes in BAT activity, transcriptional BAT markers and alterations in the gut microbiota profile or bile acid composition	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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria