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OpenTrials
Completed

NCT Number: NCT03168009

Brown Fat Activity and Bariatric Surgery

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bariatric surgery

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 30, 2017
Registry last updated
Apr 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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