Insulin Sensitivity of the Human CNS System: fMRI Study With Intranasal Insulin Application

Not Applicable

Completed

• Conditions: Obesity; Diabetes
• Interventions: Drug: Placebo; Drug: Human Insulin

• Registration Number: NCT01797601
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

The purpose of the study is to investigate whether insulin sensitivity and insulin resistance of the human brain is comparable in all insulin sensitive parts of the brain and whether correlates to other phenotypic information (i.e. whole body insulin sensitivity, BMI, age) of the study participants.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-02
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Normal routine blood works
• for women: negative pregnancy test
• healthy

Exclusion Criteria

• Type 2 diabetes
• pregnancy
• acute or chronic diseases
• Pacemakers
• Artificial heart valves
• Metal prostheses
• Implanted magnetic metal parts (screws, ...)
• Metal fragments
• Braces
• insulin pumps
• Tattoos
• claustrophobia
• reduced temperature sensation and / or increased sensitivity to warming of the body
• Ear disease or an increased sensitivity to loud noises

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo solution	Placebo	Nasal spray
Human Insulin	Human Insulin	Nasal spray

Primary Outcome Measures

Name	Time	Method
Insulin effect on regional brain activity assessed by fMRI	Change from Baseline to 15 minutes and 60 minutes post spray application

Trial Locations

Locations (1)

University of Tuebingen; 🇩🇪 Tuebingen, Germany