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Glycemic Control and Variability for Congestive Heart Failure Exacerbation

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ClinicalTrials.gov Identifier: NCT00812487
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Kathleen Dungan, Ohio State University

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

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Diabetes Mellitus Drug: Intravenous insulin Drug: Subcutaneous insulin Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Glycemic Control and Variability for Congestive Heart Failure Exacerbation
Study Start Date : January 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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


Outcome Measures
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Primary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: participants were followed for the duration of hospital stay, median hospital stay 8 day ]
    Duration of hospitalization

  2. Hospital Readmission [ Time Frame: 30 days ]
    All-cause hospital readmission within 30 days


Secondary Outcome Measures :
  1. High Frequency Heart Rate Variability [ Time Frame: 24 hours ]
    High frequency heart rate variability (HF HRV)is a measure of cardiac autonomic tone. Electrocardiographic measures were obtained using a Bionex system (Mindware, Gahanna, OH). The electrocardiogram was performed in the standard lead II configuration. Software (Mindware, Gahanna, OH) was used to derive HF HRV. HF HRV was calculated using power spectral analysis.

  2. Pre-ejection Period (PEP) [ Time Frame: 24 hours ]
    Pre-ejection period (PEP) is the time between the onset of electrical depolarization of the ventricle and the opening of the aortic valve, a measure of sympathetic tone. It is obtained noninvasively using cardiac impedance obtained using a Bionex system (Mindware, Gahanna, OH). PEP is measured in milliseconds; lower values reflect higher sympathetic tone.

  3. High Sensitivity C-reactive Protein (Hs-CRP) [ Time Frame: 72 hours ]
    High sensitivity C-reactive Protein (hs-CRP) is a measure of inflammation. hsCRP (range 0-15 mg/L) was performed using Immunlite 1000 assay (Siemens; Erlangen, Germany).

  4. Brain Natriuretic Peptide (BNP) [ Time Frame: 72 hours ]
    Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits

  5. Quality of Life [ Time Frame: 30 days ]
    Quality of Life was measured using the Minnesota Living with Heart Failure Questionnaire, which is a 21 question survey that uses a likert scale of 0-5. Each item asks over the past 4 weeks whether they have had a particular symptom of heart failure and to classify the response as no symptoms (0) to having the symptom very much (5). Responses are summed for a total score (0-105).

  6. Glycemic Lability Index (GLI) [ Time Frame: 24 hours ]
    GLI is a measure of glycemic variability. GLI is the sum of the square of the difference between successive glucose measurements divided by the difference in time between measurements

  7. Coefficient of Variation (CV) [ Time Frame: 24 hours ]
    CV is a measure of glycemic variability

  8. Mean Glucose [ Time Frame: 24 hours ]
    mean sensor glucose


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812487


Locations
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United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Kathleen Dungan
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Kathleen M Dungan, MD Ohio State University
More Information
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Responsible Party: Kathleen Dungan, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00812487    
Other Study ID Numbers: 2008H0087
1R21DK081877-01 ( U.S. NIH Grant/Contract )
First Posted: December 22, 2008    Key Record Dates
Results First Posted: December 31, 2013
Last Update Posted: December 31, 2013
Last Verified: November 2013
Keywords provided by Kathleen Dungan, Ohio State University:
congestive heart failure
diabetes mellitus
hyperglycemia
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
 Cardiovascular Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs