Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Diabetes Mellitus Clinical Trial

Official title:

Glycemic Control and Variability for Congestive Heart Failure Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00812487
• Other study ID #: 2008H0087
• Secondary ID: 1R21DK081877-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 19, 2008
• Last updated: November 9, 2013
• Start date: January 2009
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Diabetes Mellitus
• Heart Failure

Intervention

Drug:
• Intravenous insulin
Patients will receive continuous insulin infusion through the vein.
• Subcutaneous insulin
4 injections of insulin/day

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Kathleen Dungan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Length of Stay	Duration of hospitalization	participants were followed for the duration of hospital stay, median hospital stay 8 day	No
Primary	Hospital Readmission	All-cause hospital readmission within 30 days	30 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Brain Natriuretic Peptide (BNP)	Laboratory analyses were performed by the study institution's Clinical Research Center using standard commercial kits	72 hours	Yes
Secondary	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	No
Secondary	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	No
Secondary	Coefficient of Variation (CV)	CV is a measure of glycemic variability	24 hours	No
Secondary	Mean Glucose	mean sensor glucose	24 hours	No