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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 October 2012 |
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Main ID: |
NCT01409239 |
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Date of registration:
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02/08/2011 |
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Primary sponsor: |
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Public title:
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Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes
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Scientific title:
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Date of first enrolment:
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July 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01409239 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kathleen M Dungan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ohio State University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18 and above
- Admitted to a general medicine or medicine subspecialty service
- Insulin use (>20 units/day) or hyperglycemia. Hyperglycemia is defined as glucose
greater than 180 mg/dL on at least 2 occasions separated by at least 4 hours apart.
Exclusion Criteria:
- Type 1 diabetes
- Hospital stay expected less than 48 hours
- Inability to consent
- Pregnancy
- Prisoners
- Previous participation
- Autonomic neuropathy
- Conditions that preclude accurate heart rate variability monitoring: atrial
fibrillation, frequent ectopy, congestive heart failure, paced heart rhythms
- Conditions which require lower dose insulin algorithms: end stage renal or liver
disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Inpatient
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Type 2 Diabetes
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Intervention(s)
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Drug: Intravenous insulin
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Drug: Subcutaneous Insulin
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Primary Outcome(s)
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Association between the coefficient of variation and the ratio of heart rate variability at 6 hours post glucose control
[Time Frame: 6 hours]
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Difference between heart rate variability and coefficient of variation between intravenous and subcutaneous group
[Time Frame: 6, 24 hr]
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Secondary Outcome(s)
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Association between hypoglycemia area under the curve and heart rate variability
[Time Frame: 6, 24 hr]
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Association between the change in coefficient of variation for glucose and the change in heart rate variability
[Time Frame: 6, 24 hr]
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Association between the coefficient of variation of glucose and heart rate variability
[Time Frame: 24 hour]
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Association between the hyperglycemia area under the curve and heart rate variability
[Time Frame: 6, 24 hr]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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