Raclopride-PET/MRT

NCT03637075 | Completed DMC

• 1 other identifier: GK-PET/MR Tü-014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes mellitus, Type 2; cerebral insulin resistance; insulin action in the human brain; dopamine signalling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Differences between normalweight and overweight subjects regarding insulin sensitivity and availability of dopamine receptors

  0 - 60 min

• Effects of nasal insulin vs. placebo on changes in plasma insulin levels

  0 - 60min

• Effects of nasal insulin vs. placebo on changes in plasma glucose levels

  0 - 60min

• Effects of nasal insulin vs. placebo on changes in FFA levels

  0 - 60min

• Effects of nasal insulin vs. placebo on changes in prolactin levels as a proxy for the dopaminergic tonus

  0 - 60min

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Intranasal placebo administration

Other: Placebo

Intranasal insulin

ACTIVE COMPARATOR

Intranasal insulin administration

Other: intranasal insulin

Interventions

intranasal insulin OTHER

intranasal administration of insulin (160 IU)

Intranasal insulin

Placebo OTHER

placebo intranasal administration

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: single-blinded, monocentric, prospective crossover study

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 17, 2018
• Study Start: February 20, 2017
• Primary Completion: June 6, 2023
• Study Completion: December 31, 2023
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)