Glycemic Control and Variability for Congestive Heart Failure Exacerbation

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Congestive Heart Failure
• Intervention / Treatment: Drug: Intravenous insulin; Drug: Subcutaneous insulin

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: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Duration of hospitalization	participants were followed for the duration of hospital stay, median hospital stay 8 day
Hospital Readmission	All-cause hospital readmission within 30 days	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Frequency Heart Rate Variability	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.	24 hours
Pre-ejection Period (PEP)	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.	24 hours
High Sensitivity C-reactive Protein (Hs-CRP)	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).	72 hours
Brain Natriuretic Peptide (BNP)	Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits	72 hours
Quality of Life	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).	30 days
Glycemic Lability Index (GLI)	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	24 hours
Coefficient of Variation (CV)	CV is a measure of glycemic variability	24 hours
Mean Glucose	mean sensor glucose	24 hours

Collaborators and Investigators

• Sponsor: Kathleen Dungan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): September 1, 2013

Study Registration Dates

• First Submitted: December 19, 2008
• First Submitted That Met QC Criteria: December 19, 2008
• First Posted (ESTIMATE): December 22, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): December 31, 2013
• Last Update Submitted That Met QC Criteria: November 9, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: hyperglycemia; diabetes mellitus; congestive heart failure
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Heart Failure; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2008H0087; 1R21DK081877-01 (NIH)