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Glycemic Control and Variability for Congestive Heart Failure Exacerbation

K

Kathleen Dungan

Status and phase

Completed
Phase 2
Phase 1

Conditions

Diabetes Mellitus
Congestive Heart Failure

Treatments

Drug: Subcutaneous insulin
Drug: Intravenous insulin

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00812487
1R21DK081877-01 (U.S. NIH Grant/Contract)
2008H0087

Details and patient eligibility

About

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

Full 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.

Enrollment

75 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

75 participants in 2 patient groups

Intravenous insulin
Experimental group
Treatment:
Drug: Intravenous insulin
Subcutaneous Insulin
Active Comparator group
Description:
4 injections of insulin/day
Treatment:
Drug: Subcutaneous insulin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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