Starvation in the Treatment of Diabetic Ketoacidosis
Part of paid clinical trials in Lubbock, Texas.
- Sponsor
- Texas Tech University Health Sciences Center
- Study ID
- NCT06186245
- Status
- Enrolling By Invitation
Conditions
- Diabetes Mellitus
- Diabetic Ketoacidosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 89 Years
- Healthy Volunteers
- Accepted
Interventions
- Early feeding with an oral diet — OTHERParticipants in the treatment arm will be initiated on a clear liquid diet on day 1 of medical ICU admission. Diet will be progressed on day 2 to full liquid diet or diabetic diet as patient tolerates based on which diet the patient would prefer.
Study Details
Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are common, but serious metabolic disorders are often encountered in intensive care. In the intensive care setting, it is common to withhold food from patients during treatment of DKA. However, there is no evidence or current literature supporting this practice. The following proposed research investigates the initiation of an early diet versus withholding food during the treatment of diabetic ketoacidosis.
Key Dates
- Start date
- Dec 27, 2023
- Status verified
- Aug 2025
- Primary completion
- Nov 30, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Early feedingIf randomized to the experimental group, patient's diet will be advanced to clear liquid for the first day. On the second day, diet will be advanced to full liquid and advanced up to oral (carb controlled 1600 calories) diet as tolerated.
- No Intervention: Nothing per mouthPatient will be kept without PO intake until they are bridged from the insulin drip
Primary Outcome Measure
Resolution of DKA [ Time Frame: Typically resolution of DKA is 24-72 hours, may be up to 5 days in some patients ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University Medical Center | Lubbock | Texas | 79415 | - |
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