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

Obesity Clinical Trial

Official title:

Insulinsensitivität Des Menschlichen Zentralnervensystems: Kernspintomographische Untersuchung Mit Intranasaler Gabe Von Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797601
• Other study ID #: Eudra-CT: 2006-002244-29
• Secondary ID: 17/2008AMG1
• Status: Completed
• Phase: N/A
• First received: February 18, 2013
• Last updated: December 2, 2015
• Start date: February 2013
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

Drug:
• Human Insulin
160 U of insulin
• Placebo
Insulin dilution medium without insulin

Locations

Country	Name	City	State
Germany	University of Tuebingen	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	Insulin effect on regional brain activity assessed by fMRI		Change from Baseline to 15 minutes and 60 minutes post spray application	No