Insulin Sensitivity of the Brain in Pathogenesis of Diabe... | NCT00638209

Studies
Insulin Sensitivity of the Brain in Pathogenesis of Diabetes Mellitus Type 2

NCT00638209

Sponsor

University Hospital Tuebingen

Status

Unknown status

Last Update Posted

Mar 19, 2008Estimated

Enrollment

42Estimated

Phase

Not Applicable

Conditions

Human Physiology of Energy Homeostasis

Interventions

Human insulin
Saline

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

Status Module

Record Verification Date

Mar 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

May 2010Estimated

Completion Date

Not provided

First Submitted Date

Mar 12, 2008

First Submission Date that Met QC Criteria

Mar 18, 2008

First Posted Date

Mar 19, 2008Estimated

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

Mar 18, 2008

Last Update Posted Date

Mar 19, 2008Estimated

Name	Class
German Research Foundation	OTHER

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 of the human brain correlates with insulin sensitivity of the liver.

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

42Estimated

Label	Type	Description	Intervention Names
I	Active Comparator		Drug: Human insulin
P	Placebo Comparator		Drug: Saline

Name	Type	Description	Arm Group Labels	Other Names
Human insulin	Drug		I
Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insulin effect on cortical function (spectral analysis)		2 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 Risk factor(s) for type 2 diabetes (e.g. overweight, family history of diabetes)

Exclusion Criteria:

Type 2 diabetes pregnancy acute or chronic diseases

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andreas Fritsche, MD	Contact	+49 7071 29 80590		andreas.fritsche@med.uni-tuebingen.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Tuebingen, Internal Medicine IV	Recruiting	Tübingen		72076	Germany

Intervention Browse Module

MeSH Terms

ID	Term
D007328	Insulin
D012965	Sodium Chloride

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
EudraCT 2006-004734-32
KFO-114