The Effect of Hyperglycemia on LV Function and Exercise C... | NCT01071772

Studies
The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.

NCT01071772

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jun 9, 2011Estimated

Enrollment

18Actual

Phase

Phase 2

Conditions

Heart Failure
Type 2 Diabetes

Interventions

insulin

Countries

Denmark

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

Jun 2011

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

Apr 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Feb 16, 2010

First Submission Date that Met QC Criteria

Feb 18, 2010

First Posted Date

Feb 19, 2010Estimated

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

Jun 8, 2011

Last Update Posted Date

Jun 9, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

University of AarhusOTHER

Collaborators

Name	Class
Danish Heart Foundation	OTHER
Region midtjyllands sundhedsvidenskabelige forskningsfond	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Diabetes and Heart Failure are diseases with high morbidity and increased risk of death. Former investigations has shown that diabetes worsens the prognosis of heart failure. However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function.

Our hypothesis is that short term dysregulation affects left ventricular function and exercise capacity in insulin treated type 2 diabetics with and without heart failure.

To elucidate this hypothesis diabetic patients with and without heart failure will be investigated after overnight state of either high or normal blood glucose levels on two separate occasions. Metabolic and hormonal parameters will be measured. Systolic and diastolic cardiac function will be assessed, exercise capacity and post exercise regional myocardial tissue velocity as well as 6 minutes walk test will be investigated on both occasions. The study will be a randomized cross-over design.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
euglycemia	Experimental		Drug: insulin
hyperglycemia	Experimental		Drug: insulin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin	Drug	There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.	euglycemia hyperglycemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise.		1-4 weeks
Exercise capacity		1-4 months

Secondary Outcomes

Measure	Description	Time Frame
Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)		1-4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Either normal ejection fraction (EF) or heart failure (EF =<45%)
Insulin treated type 2

Exclusion Criteria:

Forme stroke with significant physically or mentally disabilitating disorders
advanced renal disease (creatinine levels >220 mM)
advanced lever disease (alanine aminotransferase > 3 times over reference level).
pregnancy
other significant disabilitating disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hans Erik Boedker, Prof, MD	Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department ofCardiology, Aarhus University Hospital, Skejby		Aarhus	Central Jutland	8200	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007328	Insulin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided