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OpenTrials
Enrolling by Invitation

NCT Number: NCT06186245

Starvation in the Treatment of Diabetic Ketoacidosis

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.

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Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center

Lubbock, Texas, 79415, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Resolution of DKA

    Time frame: Typically resolution of DKA is 24-72 hours, may be up to 5 days in some patients

    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

  2. Length of stay in the medical intensive care unit (in days).

    Time frame: Days (Typically 3-5 days in the MICU, may be up to 1 week).

    The time from admission order is placed to the time the transfer to another unit order is placed

Secondary outcomes

  1. Length of stay in the hospital

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

    from admission order time to the discharge order time

  2. mortality

    Time frame: 30 day

    If patient passes away within 30 days of participating in the study

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 29, 2023
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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