Bariatric SurgeryBACENNCT04634929
Endocrinological and Neuronal Aspects of Bariatric Surgery
An observational study of Bariatric Surgery and Obesity, run by University of Heidelberg Medical Center at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery, Obesity
- What is being tested?
- bariatric surgery and conservative diet
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2020to Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: healthy participants with obesity
Who may be able to join
- planning to undergo bariatric surgery
- planning to take part in a conservative diet
Who cannot join
- inability to undergo fMRI
- psychiatric disorders
- metabolic disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg
Joe Simon, Dr. Dipl. Psych., ++49(0)6221-56-38667, joe.simon@med.uni-heidelberg.de
About this study
Official title: 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.
- Conditions
- Bariatric Surgery, Obesity
- Being tested
- bariatric surgery, conservative diet
- Keywords
- fMRI, hormonal satiety signaling, hypothalamus, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgeryProcedure or surgery
bariatric surgery
conservative dietDietary supplement
conservative diet
| Study group | Role | What they receive |
|---|---|---|
| bariatric surgery participants | participants with obesity planning to undergo bariatric surgery Receives: Procedure: bariatric surgery | |
| conservative diet participants | participants with obesity planning to controlled conservative behavioral weight loss program Receives: Dietary Supplement: conservative diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 15 minutes before and 15 minutes after functional magnetic resonance imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start1 Dec 2020
- Primary completionDec 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Heidelberg Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Simon, University of Heidelberg Medical Center
- Investigators
- Adrian Billeter, PD, MD, Principal investigator, Department of General, Visceral, and Transplantation Surgery, University of Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634929
- Sponsor's protocol ID
- S-656/2019
- Acronym
- BACEN
- Status last verified
- Jan 2023
- First submitted
- 3 Nov 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Endocrinological and Central Neuronal Satiety Regulation Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04634929
- Acronym / sponsor ID
- BACEN / S-656/2019
- Conditions
- Bariatric Surgery, Obesity
- Keywords
- fMRI, hormonal satiety signaling, hypothalamus, weight loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bariatric surgery participants | – | Procedure: bariatric surgeryparticipants with obesity planning to undergo bariatric surgery |
| conservative diet participants | – | Dietary Supplement: conservative dietparticipants with obesity planning to controlled conservative behavioral weight loss program |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- healthy participants with obesity
Key inclusion criteria (2 listed)
- planning to undergo bariatric surgery
- planning to take part in a conservative diet
Key exclusion criteria (3 listed)
- inability to undergo fMRI
- psychiatric disorders
- metabolic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bariatric surgerybariatric surgery | Procedure or surgery | bariatric surgery participants |
| conservative dietconservative diet | Dietary supplement | conservative diet participants |
Primary outcome
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.
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.
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: No. upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Billeter, PD, MD principal investigator
Department of General, Visceral, and Transplantation Surgery, University of Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Obesity, run by University of Heidelberg Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joe J Simon, PD (++49(0)6221-56-38667, joe.simon@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.