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

NCT ID: NCT01797601

Last Updated: 2015-12-03

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-04-30

Brief Summary

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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

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Conditions

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Obesity Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Human Insulin

Nasal spray

Group Type ACTIVE_COMPARATOR

Human Insulin

Intervention Type DRUG

160 U of insulin

Placebo solution

Nasal spray

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Insulin dilution medium without insulin

Interventions

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Human Insulin

160 U of insulin

Intervention Type DRUG

Placebo

Insulin dilution medium without insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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andreas fritsche

Prof. Andreas Fritsche

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Fritsche, MD

Role: PRINCIPAL_INVESTIGATOR

Universität Tübingen

Locations

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University of Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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Kullmann S, Heni M, Veit R, Scheffler K, Machann J, Haring HU, Fritsche A, Preissl H. Selective insulin resistance in homeostatic and cognitive control brain areas in overweight and obese adults. Diabetes Care. 2015 Jun;38(6):1044-50. doi: 10.2337/dc14-2319. Epub 2015 Mar 20.

Reference Type DERIVED
PMID: 25795413 (View on PubMed)

Other Identifiers

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17/2008AMG1

Identifier Type: OTHER

Identifier Source: secondary_id

Eudra-CT: 2006-002244-29

Identifier Type: -

Identifier Source: org_study_id