Starvation in the Treatment of Diabetic Ketoacidosis

NCT06186245 | Enrolling By Invitation DMC

• 1 other identifier: TTUHSCDKA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus; Diabetic Ketoacidosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Length of stay in the hospital

  3-7 days, may be up to 1-2 weeks.

• mortality

  30 day

Study Arms (2)

Early feeding

EXPERIMENTAL

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

Nothing per mouth

NO INTERVENTION

Patient will be kept without PO intake until they are bridged from the insulin drip

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.

Early feeding

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

University Medical Center

Lubbock, Texas, 79415, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Ketoacidosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Study Officials

• Kenneth Kenneth, MD

  Texas Tech University Health Science Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 29, 2023
• Study Start: December 27, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

US (1)