Brown Fat Activity and Bariatric Surgery

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03168009
• Other study ID #: 1071/2017
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bariatric surgery-induced changes in gut microbiota, bile acid composition and other circulating factors	Any pre-versus postsurgical changes of the gut microbiota or bile acid composition or other circulating factors will be evaluated.	4 years
Secondary	Association between changes in BAT activity, transcriptional BAT markers and alterations in the gut microbiota profile or bile acid composition	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