NCT03637075Completed
Raclopride-PET/MRT
Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT
Source: ClinicalTrials.gov · Last updated 14 May 2024
Brief summary (registry, in English)
Cerebral insulin resistance plays an important role in the development of obesity and diabetes mellitus type 2. The aim of this project is to examine the effect of human nasal insulin on the dopaminergic system. Therefore, characteristics of cerebral dopamine receptors before and after administration of nasal insulin vs. placebo shall be analyzed in a randomized way. Moreover, the investigators plan to examine the insulin action on cortical and subcortical activation in humans and the interaction of dopamine metabolism with \[11C\]-Raclopride-PET/MRI. By performing fMRI measurements, insulin sensitivity of the central nervous system can be investigated simultaneously. Recruiting is planed as a two-step process.First 12 normal-weight (BMI 20-25 kg/m²) men should be examined. If first results show a insulin-dependent effect on the availability of dopamine receptors in the human brain, recruitment of 12 overweight men will get started.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 24 (actual)
- First submitted
- 3 Aug 2018
- Start date
- 20 Feb 2017
- Primary completion date
- 6 Jun 2023
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT03637075
What you commit to
- Study type: Interventional
- Participants enrolled: 24
- From 20 Feb 2017 to the primary completion date, 6 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any surgery within the last three months
Other illness
- Acute diseases such as infections (e.g.)
- Any relevant cardiovascular disease
- Any neurologic or psychiatric disease
- Known allergies
- Presence of any contraindication for the conduct of an MRI investigation, such as cardiac pacemakers, ferromagnetic haemostatic clips in the central nervous system, metallic splinters in the eye, ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators, cochlear implants, insulin pumps and nerve stimulators, prosthetic heart valves etc.
Lab values
- Hb \< 13 g/dl
Other
- Claustrophobia
Who the study is looking for
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.
- Intake of any medication
- HbA1C \<6%
- BMI 20-25 kg/m²
- Clinical routine blood parameters within the normal ranges
- All participants must agree to get informed of unexpected detected, clinical relevant findings.
Age in the registry: 20 years to 40 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Tuebingen, Department of Internal Medicine IV Coordinator of this site? Confirm its status | Tübingen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.