CHF is associated with profound metabolic and neurohormonal disturbances. These may contribute to prolonged hospitalizations and readmission rates for exacerbations. In patients with CMF, diabetes and glycemic control are independent risk factors for mortality. Therefore, hospitalized patients with CHF exacerbation may be particularly suited for improved glycemic control. However, no studies have prospectively examined whether patients hospitalized with CHF would benefit from improved glucose control. The primary aims of this study are to determine whether early intravenous (IV) insulin therapy improves hospital length of stay and autonomic tone (assessed with heart rate variability [HRV], an independent predictor of mortality in patients with CHF. In secondary aims, the study will asses whether early IV insulin impacts other measures of autonomic tone (blood pressure variability [BPV] and catecholamine levels), physiologic parameters, such as plasma volume, cardiac index, and BNP, quality of life, and finally the effects on adiponectin isomers, which are important adipokines important for insulin sensitivity. In exploratory aims, the study will examine the effect of glycemic variability and whether any cost benefit is projected with early IV insulin. This protocol will be conducted among 240 patients admitted to the OSU Ross Heart Hospital service with decompensated heart failure due to systolic dysfunction (ejection fraction<35%). Patients will be randomly assigned to one of 2 groups: (1) early IV insulin therapy targeting a blood glucose of 101-150 mg/dL, or (2) a standardized physiologic subcutaneous insulin regimen. Intravenous insulin will be continued for a minimum of 72 hours, followed by transition to subcutaneous insulin. 30 days following discharge, patients will be contacted to determine disposition and to administer quality of life scores. Primary outcomes include hospital length of stay and HRV whereas secondary outcomes include BPV, catecholamine levels, cardiac index, plasma volume, BNP, quality of life scores, and adiponectin.

Public Health Relevance

Heart failure is a leading cause of mortality from diabetes and leads to prolonged hospital stays with frequent readmissions. Preliminary studies suggest that patients with worse diabetes control have higher mortality. The present study will address whether better early diabetes control improves hospital outcomes.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Mentored Patient-Oriented Research Career Development Award (K23)
Project #
5K23DK080891-05
Application #
8326743
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Hyde, James F
Project Start
2008-09-15
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
5
Fiscal Year
2012
Total Cost
$142,533
Indirect Cost
$10,558
Name
Ohio State University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210
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Dungan, Kathleen M; Gavrilina, Tatiana; Andridge, Rebecca et al. (2014) Long-term safety and efficacy of a universal nursing-run intravenous insulin guideline. Jt Comm J Qual Patient Saf 40:119-25
Healy, Sara J; Black, Dawn; Harris, Cara et al. (2013) Inpatient diabetes education is associated with less frequent hospital readmission among patients with poor glycemic control. Diabetes Care 36:2960-7
Dungan, Kathleen M; Sagrilla, Colleen; Abdel-Rasoul, Mahmoud et al. (2013) Prandial insulin dosing using the carbohydrate counting technique in hospitalized patients with type 2 diabetes. Diabetes Care 36:3476-82
Dungan, Kathleen; Graessle, Kari; Sagrilla, Colleen (2013) The effect of congestive heart failure on sensor accuracy among hospitalized patients with type 2 diabetes. Diabetes Technol Ther 15:817-24
Dungan, K M; Osei, K; Sagrilla, C et al. (2013) Effect of the approach to insulin therapy on glycaemic fluctuations and autonomic tone in hospitalized patients with diabetes. Diabetes Obes Metab 15:558-63
Alghothani, Nora; Dungan, Kathleen M (2011) The effect of glycemic variability on counterregulatory hormone responses to hypoglycemia in young children and adolescents with type 1 diabetes. Diabetes Technol Ther 13:1085-9
Dungan, Kathleen M; Binkley, Philip; Nagaraja, Haikady N et al. (2011) The effect of glycaemic control and glycaemic variability on mortality in patients hospitalized with congestive heart failure. Diabetes Metab Res Rev 27:85-93
Dungan, K; Hall, C; Schuster, D et al. (2011) Differential response between diabetes and stress-induced hyperglycaemia to algorithmic use of detemir and flexible mealtime aspart among stable postcardiac surgery patients requiring intravenous insulin. Diabetes Obes Metab 13:1130-5
Dungan, Kathleen M; Osei, Kwame; Nagaraja, Haikady N et al. (2010) Relationship between glycemic control and readmission rates in patients hospitalized with congestive heart failure during implementation of hospital-wide initiatives. Endocr Pract 16:945-51