Starvation in the Treatment of Diabetic Ketoacidosis

Starvation in the Treatment of Diabetic Ketoacidosis: Is There Enough Evidence to Support This Practice?

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes Mellitus; Diabetic Ketoacidosis
• Intervention / Treatment: Other: Early feeding with an oral diet

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Lubbock, Texas, United States, 79415
      • University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Males and females with the diagnosis of diabetic ketoacidosis (defined as blood glucose greater than 250 mg/dL, arterial pH less than 7.3, serum bicarbonate less than 15 mEq/L, and the presence of ketonemia or ketonuria)
• Age between 18-89
• Admission to the Medical Intensive Care Unit
• Able to provide informed consent

Exclusion Criteria:

• Pregnant and breast-feeding women
• Institutionalized patients or prisoners
• Patients unable to eat by mouth, including intubation, presence of any tube used for enteral feeding (nasogastric tube, orogastric tube, PEG tube, etc.), medical conditions requiring parenteral feeding, and a history of a medical condition that prevented oral intake prior to admission, including achalasia, esophageal cancer, stroke with residual deficits preventing oral intake, amyotrophic lateral sclerosis, or head and neck trauma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Early feeding with an oral diet; 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.
No Intervention: Nothing per mouth; Patient will be kept without PO intake until they are bridged from the insulin drip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of DKA	Defined as a closed anion gap. Adjusted Anion Gap defined as (Blood Sodium - Blood Chloride - Blood Bicarbonate) + 0.25 x ((normal albumin (4.0)) x (observed albumin)); Elevated Anion Gap is >12	Typically resolution of DKA is 24-72 hours, may be up to 5 days in some patients
Length of stay in the medical intensive care unit (in days).	The time from admission order is placed to the time the transfer to another unit order is placed	Days (Typically 3-5 days in the MICU, may be up to 1 week).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in the hospital	from admission order time to the discharge order time	3-7 days, may be up to 1-2 weeks.
mortality	If patient passes away within 30 days of participating in the study	30 day

Collaborators and Investigators

• Sponsor: Texas Tech University Health Sciences Center
• Investigators: Principal Investigator: Kenneth Kenneth, MD, Texas Tech University Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: December 15, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Diabetes Mellitus; Diabetes Complications; Malnutrition; Acid-Base Imbalance; Acidosis; Ketosis; Diabetic Ketoacidosis; Starvation
• Other Study ID Numbers: TTUHSCDKA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No