Glycemic Control and Variability for Congestive Heart Failure Exacerbation
|ClinicalTrials.gov Identifier: NCT00812487|
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : December 31, 2013
Last Update Posted : December 31, 2013
|Condition or disease||Intervention/treatment||Phase|
|Congestive Heart Failure Diabetes Mellitus||Drug: Intravenous insulin Drug: Subcutaneous insulin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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
- Hospital Length of Stay [ Time Frame: participants were followed for the duration of hospital stay, median hospital stay 8 day ]Duration of hospitalization
- Hospital Readmission [ Time Frame: 30 days ]All-cause hospital readmission within 30 days
- 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.
- 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.
- 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).
- Brain Natriuretic Peptide (BNP) [ Time Frame: 72 hours ]Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits
- 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).
- 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
- Coefficient of Variation (CV) [ Time Frame: 24 hours ]CV is a measure of glycemic variability
- Mean Glucose [ Time Frame: 24 hours ]mean sensor glucose
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812487
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Kathleen M Dungan, MD||Ohio State University|