Back to resultsRaclopride-PET/MRT
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intranasal insulin
Placebo
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes mellitus, Type 2, cerebral insulin resistance, insulin action in the human brain, dopamine signalling
Eligibility Criteria
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
Sites / Locations
- University of Tuebingen, Department of Internal Medicine IVRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Intranasal insulin
Arm Description
Intranasal placebo administration
Intranasal insulin administration
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors
assessed by fMRI and Raclopride-PET/MRT
Effects of nasal insulin vs. placebo on changes in plasma insulin levels
assessed by blood sampling after application.
Effects of nasal insulin vs. placebo on changes in plasma glucose levels
assessed by blood sampling after application.
Effects of nasal insulin vs. placebo on changes in FFA levels
assessed by blood sampling after application.
Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus
assessed by blood sampling after application.
Effects of nasal insulin vs. placebo on changes in autonomic nervous system
assessed by heart rate variability.
Full Information
NCT ID
NCT03637075
First Posted
August 3, 2018
Last Updated
August 24, 2022
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT03637075
Brief Title
Raclopride-PET/MRT
Official Title
Characterization of Insulin Action and Dopamine-signaling in the Human Brain of Normal Weight and Obese Subjects by [11C]-Raclopride-PET/MRT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes mellitus, Type 2, cerebral insulin resistance, insulin action in the human brain, dopamine signalling
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
single-blinded, monocentric, prospective crossover study
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intranasal placebo administration
Arm Title
Intranasal insulin
Arm Type
Active Comparator
Arm Description
Intranasal insulin administration
Intervention Type
Other
Intervention Name(s)
intranasal insulin
Intervention Description
intranasal administration of insulin (160 IU)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo intranasal administration
Primary Outcome Measure Information:
Title
Effects of nasal insulin vs. placebo on the insulin sensitivity of the human brain as well as effects on regional availability of dopamine receptors.
Description
assessed by fMRI (insulin sensitivity of the brain measured as change in regional brain activity and Raclopride-PET/MRT (regional dopamine receptor availability).
Time Frame
0-60 min
Secondary Outcome Measure Information:
Title
Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors
Description
assessed by fMRI and Raclopride-PET/MRT
Time Frame
0 - 60 min
Title
Effects of nasal insulin vs. placebo on changes in plasma insulin levels
Description
assessed by blood sampling after application.
Time Frame
0 - 60min
Title
Effects of nasal insulin vs. placebo on changes in plasma glucose levels
Description
assessed by blood sampling after application.
Time Frame
0 - 60min
Title
Effects of nasal insulin vs. placebo on changes in FFA levels
Description
assessed by blood sampling after application.
Time Frame
0 - 60min
Title
Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus
Description
assessed by blood sampling after application.
Time Frame
0 - 60min
Title
Effects of nasal insulin vs. placebo on changes in autonomic nervous system
Description
assessed by heart rate variability.
Time Frame
-30 - 60 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Fritsche, MD
Phone
+49 7071 29 82714
Email
andreas.fritsche@med.uni-tuebingen.de
Facility Information:
Facility Name
University of Tuebingen, Department of Internal Medicine IV
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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