Glycemic Control and Variability for Congestive Heart Failure Exacerbation

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Information provided by (Responsible Party):

Kathleen Dungan, The Ohio State University

ClinicalTrials.gov Identifier:

NCT00812487

First received: December 19, 2008

Last updated: October 17, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2008

Last Updated Date

October 17, 2012

Start Date ^ICMJE

January 2009

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Glycemic Variability [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00812487 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Heart rate variability [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Cardiac Index [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Inflammatory markers [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
BNP [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Adiponectin [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
oxidative stress [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Official Title ^ICMJE

Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Brief Summary

High glucose as well as fluctuations (rapid swings) in blood glucose can contribute to severe hospital complications and even death.

Detailed Description

High glucose as well as fluctuations in blood glucose can contribute to severe hospital complications and even death. Studies also suggest that heart failure patients who have high glucose or diabetes do not live as long as patients with normal glucose. Glucose fluctuations have not been well-studied in patients with heart failure. In this study, we will determine whether better control of blood sugar fluctuations in the hospital improve outcomes. We will enroll 80 patients with severe heart failure and divide them into 2 groups. We will use intravenous (given through the vein) insulin to lower blood sugar levels in group 1, and insulin injections (under the skin) in group 2. We will determine whether intravenous insulin improves blood markers of inflammation, changes in vital signs, and other tests that predict mortality in patients with heart failure.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Congestive Heart Failure
Diabetes Mellitus

Intervention ^ICMJE

Drug: Intravenous insulin
Patients will receive continuous insulin infusion through the vein.
Drug: Subcutaneous insulin
4 injections of insulin/day

Study Arm (s)

Experimental: Intravenous insulin
Intervention: Drug: Intravenous insulin
Active Comparator: Subcutaneous Insulin
4 injections of insulin/day

Intervention: Drug: Subcutaneous insulin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 18 and above
Admitted (less than 48 hours) to the OSU Ross Heart Hospital with worsening heart failure
Hyperglycemia or diabetes. Hyperglycemia is defined as blood glucose greater than 150 mg/dL on at least 2 occasions separated by at least 4 hours apart, insulin use, or HbA1c >6.5%.

Exclusion Criteria:

Type 1 diabetes
Receiving comfort care measures only
Hospital stay expected to be less than 2 days
Pregnancy
Prisoners
Participation in the study on prior hospitalizations
Acute myocardial infarction within 3 months
End stage renal or liver disease

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00812487

Other Study ID Numbers ^ICMJE

2008H0087, 1R21DK081877-01

Has Data Monitoring Committee

Yes

Responsible Party

Kathleen Dungan, The Ohio State University

Study Sponsor ^ICMJE

Kathleen Dungan

Collaborators ^ICMJE

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Kathleen M Dungan, MD

Ohio State University

Information Provided By

Ohio State University

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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