Starvation in the Treatment of Diabetic Ketoacidosis

Launched by TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER · Dec 15, 2023

Keywords

ClinConnect Summary

This study is testing whether starting to eat earlier in adults with diabetic ketoacidosis (DKA) is safe and helps recovery. People in the trial are randomly placed into two groups: one group begins a diet with clear liquids on day 1, progresses to full liquids and then to a light, carb-controlled solid diet as they tolerate it; the other group remains without anything by mouth until they are taken off the insulin drip. It’s a randomized, parallel design and aims to enroll about 200 adults (ages 18–89) with DKA who are in the medical ICU.

To be eligible, participants must have DKA defined by specific blood test results and be able to give informed consent. Exclusion criteria include pregnancy, in-prison status, inability to eat by mouth or needing tube feeding, or conditions that would prevent oral intake. The study looks mainly at how quickly DKA resolves and how long people stay in the ICU, with secondary outcomes including total hospital stay and 30-day mortality. The trial is based at University Medical Center in Lubbock, Texas, led by Texas Tech University Health Sciences Center, and is overseen by a Data Monitoring Committee.

Gender

ALL

Eligibility criteria

• 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.