Effect of Bariatric Surgery on Brain Insulin Sensitivity (NCT03705923) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Bariatric Surgery on Brain Insulin Sensitivity
Stopped: low recruitment
Germany3 participantsStarted 2018-12-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Central insulin sensitivity
Timeframe: Central insulin sensitivity will be assessed as change before bariatric surgery and 6 months afterwards.
2
Peripheral insulin sensitivity
Timeframe: Peripheral insulin sensitivity will be assessed by oral glucose tolerance as change before bariatric surgery and 6 months afterwards.