Endocrinological and Neuronal Aspects of Bariatric Surgery

Obesity Clinical Trial

— BACEN  

Official title:

Changes in Endocrinological and Central Neuronal Satiety Regulation Following Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04634929
• Other study ID #: S-656/2019
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: February 2024

Study information

• Verified date: January 2023
• Source: University of Heidelberg Medical Center
• Contact: Joe J Simon, PD
• Phone: ++49(0)6221-56-38667
• Email: joe.simon[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2024
• Est. primary completion date: December 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

Intervention

Procedure:
• bariatric surgery
bariatric surgery

Dietary Supplement:
• conservative diet
conservative diet

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Heidelberg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight change	Change in weight following bariatric surgery or dietary intervention	12 months
Primary	Change in Functional magnetic resonance imaging following intravenous glucose infusion.	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.
Primary	Experimental functional magnetic resonance imaging task (gustatory stimulation).	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.
Primary	Assessment of glucose-induced changes in peripheral ghrelin using blood samples.	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