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NCT01409239 · ClinicalTrials.gov registry record · Phase 4
Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes
A Phase 4 study of Type 2 Diabetes and Inpatient, sponsored by Kathleen Dungan.
- Completed
- Registry status
- Phase 4
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT01409239: Completed Phase 4 study of Type 2 Diabetes and Inpatient, sponsored by Kathleen Dungan.
NCT01409239 is a Phase 4 study of Type 2 Diabetes and Inpatient that has completed, run by Kathleen Dungan. The registered enrollment target is 42 participants, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01409239, a Phase 4 study of Type 2 Diabetes and Inpatient, has completed, sponsored by Kathleen Dungan.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Glycemic variability has been associated with mortality in hospitalized patients with hyperglycemia. However, it is unknown how modulation of glycemic variability would impact outcomes. One possibility is that glycemic variability could impact autonomic tone. In particular, heart rate variability (HRV) measurement is a sensitive marker for measuring autonomic tone, and aberrations in HRV have been associated with mortality. The current randomized pilot study will compare the effects of continuous intravenous (IV) insulin and subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized non-critically ill patients with diabetes. Non-critically ill patients who are hyperglycemic or are requiring at least 20 units of insulin per day will be included. Patients with conditions that preclude accurate HRV readings (such as atrial fibrillation or paced rhythms) will be excluded. Patients randomized to intravenous insulin will receive the therapy for 24 hours according to our standard hospital guideline. Patients randomized to subcutaneous (SQ) insulin will receive basal bolus therapy using insulin analogues. All therapies will begin between 8 and 10 AM. Patients will undergo repeated heart rate variability recordings during the 24 hour period. Blood draws will be collected at baseline and at 24 hours for measurement of catecholamines, insulin, and c-peptide. Glycemic variability will be measured using a continuous subcutaneous glucose monitor and reported as coefficient of variation. The primary outcome measure is low frequency-to-high frequency power spectrum ratio of heart rate variability. 1. Glycemic variability is associated with unfavorable changes in autonomic tone, as assessed by low frequency (LF)/high frequency (HF) HRV ratio, independent of changes in overall glycemia. 2. Short-term increases in glycemic variability, followed by more prolonged glycemic stability are observed in generalized hospitalized patients treated with intraven
Conditions Studied
Interventions
- DRUG Intravenous insulin
- DRUG Subcutaneous Insulin
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01409239
The ClinicalTrials.gov registry entry for NCT01409239 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,102-participant average among 288 other Type 2 Diabetes trials with a reported enrollment target (96% lower). The listed sponsor is Kathleen Dungan, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Type 2 Diabetes appearing as the primary indexed condition, and to 2 interventions - of which Intravenous insulin is the first listed.
NCT01409239 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT01409239 about?
NCT01409239 is a clinical study titled "Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes". Glycemic variability has been associated with mortality in hospitalized patients with hyperglycemia. However, it is unknown how modulation of glycemic variability would impact outcomes. One possibility is that glycemic variability could impact autonomic tone. In particular, heart rate variability (H...
What is the current status of trial NCT01409239?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 42 participants. The study started on 2011-07. Estimated completion is 2012-12.
What conditions does trial NCT01409239 study?
This clinical trial studies the following conditions: Type 2 Diabetes, Inpatient.
What interventions are being tested in trial NCT01409239?
The interventions under investigation include: Intravenous insulin (DRUG), Subcutaneous Insulin (DRUG).
Who is sponsoring clinical trial NCT01409239?
This trial is sponsored by Kathleen Dungan, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01409239 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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