Early Feeding for Diabetic Ketoacidosis

Overseen By Kenneth Iwuji, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Tech University Health Sciences Center

Disqualifiers: Pregnancy, Institutionalization, Eating inability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3-5 days

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is early oral feeding safe for patients with diabetes after surgery?

Research indicates that early oral feeding is generally safe for patients with type II diabetes after esophageal surgery, suggesting it may be safe in similar contexts. ^{1 2 3 4 5}

How does early feeding with an oral diet differ from other treatments for diabetic ketoacidosis?

Early feeding with an oral diet for diabetic ketoacidosis is unique because it focuses on introducing food earlier in the treatment process, which is not typically part of standard care. Standard treatments usually emphasize insulin administration, fluid replacement, and electrolyte management without immediate oral feeding. ^{6 7 8 9 10}

Research Team

Kenneth Kenneth, MD

Principal Investigator

Texas Tech University Health Science Center

Eligibility Criteria

This trial is for men and women aged 18-89 who are in the Medical Intensive Care Unit, can give informed consent, and have diabetic ketoacidosis (high blood sugar over 250 mg/dL, low arterial pH below 7.3, low serum bicarbonate under 15 mEq/L, with ketones in blood or urine).

Inclusion Criteria

You are able to understand and agree to take part in the study.

I am admitted to the ICU for serious medical issues.

I have been diagnosed with diabetic ketoacidosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants are randomized to either early feeding or nothing per mouth during the treatment of diabetic ketoacidosis

3-5 days

Daily monitoring in the intensive care unit

Follow-up

Participants are monitored for safety and effectiveness after treatment, including resolution of DKA and mortality within 30 days

30 days

Treatment Details

Interventions

• Early feeding with an oral diet

Trial Overview The study is looking at whether eating early on during treatment for diabetic ketoacidosis helps patients recover better compared to not eating at all. It's testing if starting an oral diet sooner has any benefits.

Participant Groups

Group I: Early feeding Experimental Treatment 1 Intervention

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.

Group II: Nothing per mouth Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials

107

Recruited

11,500+

Findings from Research

A meta-analysis of seven trials involving 587 patients found that early oral feeding after elective colorectal surgery significantly reduced the length of hospital stay by an average of 1.58 days compared to traditional feeding methods.

Early oral feeding also led to a decrease in total postoperative complications, with a relative risk reduction of 30%, while showing no significant differences in serious complications like anastomotic dehiscence or pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early versus traditional postoperative oral feeding in patients undergoing elective colorectal surgery: a meta-analysis of randomized clinical trials. Zhuang, CL., Ye, XZ., Zhang, CJ., et al.[2014]

References

1. United States pubmed.ncbi.nlm.nih.gov

Improved Glucose Profile in Patients With Type 2 Diabetes With a New, High-Protein, Diabetes-Specific Tube Feed During 4 Hours of Continuous Feeding. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Early versus traditional postoperative oral feeding in patients undergoing elective colorectal surgery: a meta-analysis of randomized clinical trials. [2014]

3. England pubmed.ncbi.nlm.nih.gov

Effect of bolus enteral tube feeding on body weight in ambulatory adults with obesity and type 2 diabetes: a feasibility pilot randomized trial. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Safety analysis of early oral feeding after esophagectomy in patients complicated with diabetes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Nutrition and the management of type 2 diabetes. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Diabetic ketoacidosis. Why early detection and aggressive treatment are crucial. [2016]

7. Scotland pubmed.ncbi.nlm.nih.gov

Analysis of the safety and efficacy of diabetic ketoacidosis management in a Community General Hospital, 2001-2010: a descriptive study. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Successful treatment of type 1 diabetes and seizures with combined ketogenic diet and insulin. [2017]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Management of diabetic ketoacidosis. [2018]

10. Sweden pubmed.ncbi.nlm.nih.gov

Severe diabetic ketoacidosis in combination with starvation and anorexia nervosa at onset of type 1 diabetes: a case report. [2021]