Effect of Weight Loss on Brain Insulin Sensitivity in Humans (NCT02991365) | Clinical Trial Compass
UnknownNot Applicable
Effect of Weight Loss on Brain Insulin Sensitivity in Humans
Germany40 participantsStarted 2016-12
Plain-language summary
Obesity if known to be associated with brain insulin resistance in humans. This condition has not only implication for the brain but also for whole-body energy homeostasis. Research in rodents indicates that weight loss is able to improve insulin sensitivity of the brain. The current project will test this hypothesis in humans. Therefore, brain insulin sensitivity will be assessed by fMRI in combination with intranasal insulin administration, using an established protocol. Furthermore, effects of daily administration of insulin nasal spray (versus placebo) over 8 weeks will be assessed as secondary (exploratory) variables.
Who can participate
Age range
40 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:
* HbA1c \<6.5%
* Age between 40 and 75 years
* No intake of antidiabetic drugs or drugs for weight reduction
* no steroid intake
* Stable medication over 10 weeks before the start 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
* Simultaneous participation in other studies
* 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
brain insulin sensitivity
Timeframe: 30 minutes after administration of nasal insulin