Glycemic Control and Variability for Congestive Heart Failure Exacerbation - Full Text View

Sponsored by:	Ohio State University
Information provided by:	Ohio State University
ClinicalTrials.gov Identifier:	NCT00812487

Purpose

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

Condition	Intervention	Phase
Congestive Heart Failure Diabetes Mellitus	Drug: Intravenous insulin Drug: Subcutaneous insulin	Phase I Phase II

MedlinePlus related topics: Diabetes Heart Failure

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Further study details as provided by Ohio State University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intravenous insulin: Experimental	Drug: Intravenous insulin Patients will receive continuous insulin infusion through the vein.
Subcutaneous Insulin: Active Comparator 4 injections of insulin/day	Drug: Subcutaneous insulin 4 injections of insulin/day

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812487

Contacts

Contact: Kathleen M Dungan, MD

614-292-3800

kathleen.dungan@osumc.edu

Locations

United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University

Investigators

Principal Investigator:

Kathleen M Dungan, MD

Ohio State University

More Information

Responsible Party:	The Ohio State University ( Kathleen Dungan )
Study ID Numbers:	1 R21 DK081877-01
Study First Received:	December 19, 2008
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00812487
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University:

congestive heart failure
diabetes mellitus
hyperglycemia

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Metabolic Diseases
Hyperglycemia
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009