ObesityNCT03705923
Effect of Bariatric Surgery on Brain Insulin Sensitivity
A study testing Bariatric surgery in people with Obesity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Adiposity is associated with prediabetes and type 2 diabetes. In very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to 1 Dec 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years
- planned bariatric surgery (laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy)
- stable medication 10 weeks before begin of the study
Who cannot join
- persons who wear non-removable metal parts in or on the body.
- persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
- cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
- persons with hearing impairment or increased sensitivity to loud noises
- people with claustrophobia
- minors or non-consenting subjects are also excluded
Show all 10Show fewer
- subjects with an operation less than 3 months
- neurological and psychiatric disorders
- subjects with hemoglobin Hb <11 g / dl
- hypersensitivity to any of the substances used
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tuebingen, Department of Internal Medicine IV
Tübingen, 72076
About this study
Official title: Metabolic Characterization of Subjects With Adipositas Before and After Bariatric Surgery
Adiposity is associated with prediabetes and type 2 diabetes. In very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. So far the molecular mechanisms that lead to an improvement of type 2 diabetes after bariatric surgery are not fully understood. It is planned to characterize the metabolic and neuroendocrine changes in subjects before and after bariatric surgery. One special focus of the study is brain insulin resistance, a condition known to be associated with obesity with impact on the brain and whole body metabolism.
- Conditions
- Obesity
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | Experimental | Subjects undergoing laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central insulin sensitivity
Central insulin sensitivity will be assessed by fMRI after application of nasal insulin or placebo.
Measured: Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.
Peripheral insulin sensitivity
Peripheral insulin sensitivity will be assessed by oral glucose tolerance test.
Measured: Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards.
Secondary outcomes (9)
Whole body fat distribution
Body fat distribution will be assessed by MRI
Measured: Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards.
Liver fat content
Liver fat content will be assessed by MRS
Measured: Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards.
Metabolic rate
Metabolic rate will be assessed by indirect calorimetry
Measured: Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards.
Response to food cues
Food cues will be rated for palatability on a visual analogue scale
Measured: Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards.
Trail-making test
Trail-making test will be performed
Measured: Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards.
Hopkins-verbal learning test
Hopkins-verbal learning test will be performed
Measured: Change in Hopkins-verbal learning test will be assessed before bariatric surgery and 6 months afterwards.
Glucose tolerance
Glucose tolerance will be assessed by 75g oral glucose tolerance test.
Measured: Glucose tolerance will be assessed by 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
Insulin secretion
Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test.
Measured: Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
Weight loss
Body weight will be measured before and 6 months after surgery.
Measured: Weight loss before and 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Dec 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: low recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Heni, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705923
- Sponsor's protocol ID
- 714/2017BO1
- Status last verified
- Dec 2021
- First submitted
- 9 Aug 2018
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Characterization of Subjects With Adipositas Before and After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03705923
- Acronym / sponsor ID
- 714/2017BO1
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 15 Oct 2018 (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.
Adiposity is associated with prediabetes and type 2 diabetes. In very severe cases of adiposity in combination with type 2 diabetes, bariatric surgery has proven to be a successful therapy option. So far the molecular mechanisms that lead to an improvement of type 2 diabetes after bariatric surgery are not fully understood. It is planned to characterize the metabolic and neuroendocrine changes in subjects before and after bariatric surgery. One special focus of the study is brain insulin resistance, a condition known to be associated with obesity with impact on the brain and whole body metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | Experimental | Procedure: Bariatric surgerySubjects undergoing laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 18 and 75 years
- planned bariatric surgery (laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy)
- stable medication 10 weeks before begin of the study
Key exclusion criteria (10 listed)
- persons who wear non-removable metal parts in or on the body.
- persons with reduced temperature sensitivity and / or increased sensitivity to heating of the body
- cardiovascular disease can not be ruled out, e.g. manifest coronary heart disease, heart failure greater than NYHA 2, previous heart attack, stroke condition
- persons with hearing impairment or increased sensitivity to loud noises
- people with claustrophobia
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 surgerylaparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy | Procedure or surgery | Bariatric surgery |
Primary outcome
Central insulin sensitivity
Time frame: Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.
Central insulin sensitivity will be assessed by fMRI after application of nasal insulin or placebo.
Peripheral insulin sensitivity
Time frame: Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards.
Peripheral insulin sensitivity will be assessed by oral glucose tolerance test.
9 secondary outcomes
Whole body fat distribution
Time frame: Body fat distribution will be assessed by MRI prior bariatric surgery and 6 months afterwards.
Liver fat content
Time frame: Liver fat content will be assessed by MRS prior bariatric surgery and 6 months afterwards.
Metabolic rate
Time frame: Metabolic rate will be assessed by indirect calorimetry prior bariatric surgery and 6 months afterwards.
Response to food cues
Time frame: Change in response to food cues will be assessed before bariatric surgery and 6 months afterwards.
Trail-making test
Time frame: Change in trail-making test will be assessed before bariatric surgery and 6 months afterwards.
Hopkins-verbal learning test
Time frame: Change in Hopkins-verbal learning test will be assessed before bariatric surgery and 6 months afterwards.
Glucose tolerance
Time frame: Glucose tolerance will be assessed by 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
Insulin secretion
Time frame: Insulin secretion will be assessed by insulin measurements during 75g oral glucose tolerance test prior to bariatric surgery and 6 months afterwards.
Weight loss
Time frame: Weight loss before and 6 months after surgery.
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Martin Heni, MD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery in people with Obesity, run by University Hospital Tuebingen 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 5 Jan 2022. 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?
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central insulin sensitivity (time frame: Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.). The study lists 2 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 5 Jan 2022; AzTrials last refreshed its copy on 5 Nov 2026.