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Glycemic Control and Variability for Congestive Heart Failure Exacerbation

NCT ID: NCT00812487

Last Updated: 2013-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Congestive Heart Failure Diabetes Mellitus

Keywords

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congestive heart failure diabetes mellitus hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous insulin

Group Type EXPERIMENTAL

Intravenous insulin

Intervention Type DRUG

Patients will receive continuous insulin infusion through the vein.

Subcutaneous Insulin

4 injections of insulin/day

Group Type ACTIVE_COMPARATOR

Subcutaneous insulin

Intervention Type DRUG

4 injections of insulin/day

Interventions

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Intravenous insulin

Patients will receive continuous insulin infusion through the vein.

Intervention Type DRUG

Subcutaneous insulin

4 injections of insulin/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 18 and above
* Admitted (less than 48 hours) to the 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Kathleen Dungan

OTHER

Sponsor Role lead

Responsible Party

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Kathleen Dungan

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kathleen M Dungan, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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1R21DK081877-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2008H0087

Identifier Type: -

Identifier Source: org_study_id