Endocrinological and Neuronal Aspects of Bariatric Surgery (BACEN)

January 12, 2023 updated by: Joe Simon, University of Heidelberg Medical Center

Changes in Endocrinological and Central Neuronal Satiety Regulation Following Bariatric Surgery

The overall aim of the proposed project is to investigate the contribution of changes in neuronal food processing, hypothalamic reactivity and hormonal factors to weight loss after bariatric surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

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

Study Contact

Study Locations

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy participants with obesity

Description

Inclusion Criteria:

  • planning to undergo bariatric surgery
  • planning to take part in a conservative diet

Exclusion Criteria:

  • inability to undergo fMRI
  • psychiatric disorders
  • metabolic disorders

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
bariatric surgery participants
participants with obesity planning to undergo bariatric surgery
Procedure: bariatric surgery
bariatric surgery
conservative diet participants
participants with obesity planning to controlled conservative behavioral weight loss program
Dietary supplement: conservative diet
conservative diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional magnetic resonance imaging following intravenous glucose infusion.
Time Frame: 2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.
Change in responsivity of the hypothalamus (extracted as percent signal change) as the core region of homeostatic control will be assessed after an intravenous glucose infusion (by calculating the area under the curve of hypothalamic responsivity) before and after bariatric surgery or dietary intervention.
2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.
Experimental functional magnetic resonance imaging task (gustatory stimulation).
Time Frame: 2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.
Neuronal gustatory processing of food stimuli will be assessed (ingestion of sweet liquids using a gustometer) using a general linear model (comparing brain activation during ingestion of sweet liquids with brain activation during the ingestion of water) and within as well as between groups analyses. Changes in neural gustatory processing of food stimuli will be assessed before and after bariatric surgery or dietary intervention.
2 weeks before surgery or start of dietary intervention and 2 weeks after surgery or start of dietary intervention.
Assessment of glucose-induced changes in peripheral ghrelin using blood samples.
Time Frame: 15 minutes before and 15 minutes after functional magnetic resonance imaging
Blood is collected to measure the concentration of peripheral ghrelin as an indicator of hormonal satiety signaling. Blood samples are collected at the beginning and end of each experimental session to assess the influence of intravenuous infusion of glucose on ghrelin signaling. Blood samples will be analysed using using commercially available kits (enzyme-linked immunosorbent assay).
15 minutes before and 15 minutes after functional magnetic resonance imaging

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight change
Time Frame: 12 months
Change in weight following bariatric surgery or dietary intervention
12 months

Collaborators and Investigators

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

Sponsor

University of Heidelberg Medical Center

Investigators

  • Principal Investigator: Adrian Billeter, PD, MD, Department of General, Visceral, and Transplantation Surgery, University of Heidelberg

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)

December 1, 2020

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

November 3, 2020

First Submitted That Met QC Criteria

November 17, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 12, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • S-656/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

upon reasonable request

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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