NCT00812253

Brief Summary

Patients with heart failure often have high blood sugar (glucose).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 7, 2014

Completed
Last Updated

January 2, 2018

Status Verified

December 1, 2017

Enrollment Period

4.7 years

First QC Date

December 19, 2008

Results QC Date

June 12, 2014

Last Update Submit

December 3, 2017

Conditions

Congestive Heart FailureDiabetes Mellitus

Keywords

Heart failureHyperglycemiaHospitalDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay

    Duration of hospitalization in days

    Days

Secondary Outcomes (5)

  • Hospital Readmission

    30 days

  • Heart Rate Variability

    72 hours

  • Change in Quality of Life

    30 day

  • Brain Natriuretic Peptide (BNP)

    72 hours

  • Cardiac Output

    72 hours

Study Arms (2)

Intravenous Insulin

EXPERIMENTAL
Drug: Intravenous insulin

Subcutaneous Insulin

ACTIVE COMPARATOR

Basal bolus insulin (4 injections per day)

Drug: Subcutaneous insulin

Interventions

Intravenous insulinDRUG

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Intravenous Insulin
Subcutaneous insulinDRUG

Half of subjects will receive insulin through the intravenous route while the other half will receive 4 injections per day.

Subcutaneous Insulin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 and above
  • Admitted (less than 48 hours) to the OSU Ross Heart Hospital 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%.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Heart FailureDiabetes MellitusHyperglycemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Limitations and Caveats

HRV and impedance data were limited due to medical devices, conditions that preclude measurement of HRV such as arrhythmias, or technical problems (N=2). The remainder of missing data were due to early hospital discharge.

Results Point of Contact

Title
Kathleen Dungan
Organization
The Ohio State University
kathleen.dungan@osumc.edu
6146853333

Study Officials

  • Kathleen M Dungan, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

January 1, 2009

Primary Completion

September 1, 2013

Study Completion

May 1, 2014

Last Updated

January 2, 2018

Results First Posted

August 7, 2014

Record last verified: 2017-12

Locations

US(1)