Endocrinological and Neuronal Aspects of Bariatric Surgery

NCT04634929 | Unknown

• 1 other identifier: S-656/2019
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bariatric Surgery; Obesity

Keywords

fMRI; hormonal satiety signaling; hypothalamus; weight loss

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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

Other Outcomes (1)

• Weight change

  12 months

Study Arms (2)

bariatric surgery participants

participants with obesity planning to undergo bariatric surgery

Procedure: bariatric surgery

conservative diet participants

participants with obesity planning to controlled conservative behavioral weight loss program

Dietary Supplement: conservative diet

Interventions

bariatric surgery PROCEDURE

bariatric surgery

bariatric surgery participants

conservative diet DIETARY_SUPPLEMENT

conservative diet

conservative diet participants

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

healthy participants with obesity

You may qualify if:

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

You may not qualify if:

• inability to undergo fMRI
• psychiatric disorders
• metabolic disorders

Sponsors & Collaborators

• University of Heidelberg Medical Center: lead

Study Sites (1)

University Hospital Heidelberg

Heidelberg, Germany

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Adrian Billeter, PD, MD

  Department of General, Visceral, and Transplantation Surgery, University of Heidelberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe J Simon, PD

CONTACT

++49(0)6221-56-38667; joe.simon@med.uni-heidelberg.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 18, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)