Raclopride-PET/MRT

NCT ID: NCT03637075

Last Updated: 2024-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

single-blinded, monocentric, prospective crossover study
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Intranasal placebo administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo intranasal administration

Intranasal insulin

Intranasal insulin administration

Group Type ACTIVE_COMPARATOR

intranasal insulin

Intervention Type OTHER

intranasal administration of insulin (160 IU)

Interventions

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intranasal insulin

intranasal administration of insulin (160 IU)

Intervention Type OTHER

Placebo

placebo intranasal administration

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GK-PET/MR Tü-014

Identifier Type: -

Identifier Source: org_study_id

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