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 — OTHER
    Participants 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 feeding
    If 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 mouth
    Patient 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)

FacilityCityStateZIPSite coordinators
University Medical CenterLubbockTexas79415-

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