Starvation in the Treatment of Diabetic Ketoacidosis

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06186245
• Other study ID #: TTUHSCDKA
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 27, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acidosis
• Diabetes Mellitus
• Diabetic Ketoacidosis
• Ketosis
• Starvation

Intervention

Other:
• Early 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.

Locations

Country	Name	City	State
United States	University Medical Center	Lubbock	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Length of stay in the hospital	from admission order time to the discharge order time	3-7 days, may be up to 1-2 weeks.
Secondary	mortality	If patient passes away within 30 days of participating in the study	30 day