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| Sponsor: | Kathleen Dungan |
|---|---|
| Information provided by (Responsible Party): | Kathleen Dungan, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT01409239 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Inpatient |
Drug: Intravenous insulin Drug: Subcutaneous Insulin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Subcutaneous Insulin |
Drug: Subcutaneous Insulin
basal bolus insulin using carb counting technique and insulin analogues
|
| Experimental: Intravenous insulin |
Drug: Intravenous insulin
24 hr IV insulin administered according to hospital guideline
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kathleen M Dungan, MD | 615-292-3800 | kathleen.dungan@osumc.edu |
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Kathleen M Dungan, MD 614-292-3800 kathleen.dungan@osumc.edu | |
| Principal Investigator: | Kathleen M Dungan, MD | Ohio State University |
More Information
| Responsible Party: | Kathleen Dungan, Assistant Professor, The Ohio State University |
| ClinicalTrials.gov Identifier: | NCT01409239 History of Changes |
| Other Study ID Numbers: | CCTS869 |
| Study First Received: | August 2, 2011 |
| Last Updated: | March 21, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
hospital diabetes glycemic variability autonomic tone |
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |