Raclopride-PET/MRT

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637075
• Other study ID #: GK-PET/MR Tü-014
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 31, 2023
• Est. primary completion date: June 6, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Acute diseases such as infections (e.g.)

• Any relevant cardiovascular disease

• Any surgery within the last three months

• Any neurologic or psychiatric disease

• Known allergies

• Hb < 13 g/dl

• 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.

• Claustrophobia

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• intranasal insulin
intranasal administration of insulin (160 IU)
• Placebo
placebo intranasal administration

Locations

Country	Name	City	State
Germany	University of Tuebingen, Department of Internal Medicine IV	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors.	assessed by fMRI (insulin sensitivity of the brain measured as change in regional brain activity and Raclopride-PET/MRT (regional dopamine receptor availability).	0-60 min
Secondary	Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors	assessed by fMRI and Raclopride-PET/MRT	0 - 60 min
Secondary	Effects of nasal insulin vs. placebo on changes in plasma insulin levels	assessed by blood sampling after application.	0 - 60min
Secondary	Effects of nasal insulin vs. placebo on changes in plasma glucose levels	assessed by blood sampling after application.	0 - 60min
Secondary	Effects of nasal insulin vs. placebo on changes in FFA levels	assessed by blood sampling after application.	0 - 60min
Secondary	Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus	assessed by blood sampling after application.	0 - 60min
Secondary	Effects of nasal insulin vs. placebo on changes in autonomic nervous system	assessed by heart rate variability.	-30 - 60 min