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Should DKA patients fast or feast? trial tests early eating in the ICU

NCT ID NCT06186245

Symptom relief Sponsor: Texas Tech University Health Sciences Center Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Doctors often withhold food from patients being treated for diabetic ketoacidosis in the intensive care unit, but no evidence supports this practice. Researchers are testing whether starting an oral diet early in treatment helps resolve the condition faster and shortens ICU and hospital stays. The trial enrolls adults aged 18 to 89 admitted to the medical ICU with diabetic ketoacidosis. Participants either begin a clear liquid diet on day one and progress as tolerated, or follow standard care with food withheld.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Early feeding with an oral diet
What this could lead to
If early eating helps, it could change standard ICU care for diabetic ketoacidosis and help patients recover faster. It may also shorten hospital stays and reduce complications from prolonged fasting.
What could go wrong
This is a small study at one center, so results may not apply everywhere. Early feeding could cause nausea, vomiting, or other issues in some patients, and the trial may not show a clear benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

93 people

The number who actually took part.

Started

Dec 2023

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus diabetic ketoacidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Diabetic ketoacidosis

Contacts and locations

Locations

  • University Medical Center

    Lubbock, Texas, 79415, United States

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