CClinicalTrials.gg
CompletedNCT06186245Updated Sep 11, 2026

Starvation in the Treatment of Diabetic Ketoacidosis

An interventional study of Early feeding with an oral diet in Diabetes Mellitus and Diabetic Ketoacidosis, sponsored by Texas Tech University Health Sciences Center. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Texas Tech University Health Sciences Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus
  • Diabetic Ketoacidosis
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In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 93 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Texas Tech University Health Sciences Center is the lead sponsor of 97 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
93 participants (actual)

Study 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.

    Other: Early feeding with an oral diet

  • No intervention
    Nothing per mouth

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

Interventions

  • OtherEarly 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.

06

What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

  1. Length of stay in the hospital

    from admission order time to the discharge order time

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

  2. mortality

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

    Time frame: 30 day

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Study locations

1 site
  • University Medical Center
    Lubbock, Texas 79415, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 1, 2023
  • Informed consent form · May 16, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06186245
Lead sponsor
Texas Tech University Health Sciences Center
Responsible party
Sponsor
First posted
Dec 29, 2023
Start date
Dec 27, 2023
Primary completion
Jul 25, 2025
Completion
Dec 31, 2025
Last update
Sep 11, 2026

Study contacts

Kenneth Kenneth, MD
principal investigator · Texas Tech University Health Sciences Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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