Insulin Sensitivity of the Human CNS System: fMRI Study W... | NCT01797601

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

NCT01797601

Sponsor

University Hospital Tuebingen

Status

Completed

Last Update Posted

Dec 3, 2015Estimated

Enrollment

48Actual

Phase

Not Applicable

Conditions

Obesity
Diabetes

Interventions

Human Insulin
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
17/2008AMG1	Other Identifier	Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Apr 2014Actual

Completion Date

Apr 2014Actual

First Submitted Date

Feb 18, 2013

First Submission Date that Met QC Criteria

Feb 20, 2013

First Posted Date

Feb 22, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

andreas fritsche, Prof. Andreas Fritsche, University Hospital TuebingenPrincipal Investigator

Lead Sponsor

University Hospital TuebingenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Human Insulin	Active Comparator	Nasal spray	Drug: Human Insulin
Placebo solution	Placebo Comparator	Nasal spray	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Human Insulin	Drug	160 U of insulin	Human Insulin
Placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andreas Fritsche, MD	Universität Tübingen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tuebingen		Tübingen		72074	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25795413	Derived	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.

ID	Term
D009765	Obesity
D003920	Diabetes Mellitus

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones