Early Feeding for Diabetic Ketoacidosis

CS
KI
Overseen ByKenneth Iwuji, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Texas Tech University Health Sciences Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether starting an early diet can help treat diabetic ketoacidosis (DKA), a serious condition that causes high blood sugar and acid buildup in the blood. Typically, patients with DKA in intensive care do not receive food immediately. This study aims to determine if eating sooner could be beneficial. It includes two groups: one will begin with a controlled diet starting with liquids (early feeding with an oral diet), and the other will not eat until after their initial treatment. People with DKA in the intensive care unit who can eat and provide consent might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore new treatment possibilities for DKA.

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.

What prior data suggests that early feeding with an oral diet is safe for patients with diabetic ketoacidosis?

Research has shown that starting solid food early for patients with diabetic ketoacidosis (DKA) is generally safe. Several studies indicate that feeding patients within the first 24 hours does not cause additional issues and often results in a shorter hospital stay. One study found that early eating did not increase DKA complications and might even aid faster recovery. Overall, the evidence suggests that early feeding could be a safe option for patients with DKA.12345

Why are researchers excited about this trial?

Researchers are excited about the early feeding approach for diabetic ketoacidosis (DKA) because it challenges the traditional method of keeping patients without oral intake (NPO) until stabilized. Typically, DKA patients are managed with insulin drips and fluid replacement, delaying any oral intake. The innovative aspect of this trial is the introduction of an oral diet sooner, which could potentially enhance recovery by providing necessary nutrients earlier. This approach may help stabilize blood sugar levels and improve patient comfort, offering a more holistic and patient-friendly treatment option.

What evidence suggests that early feeding is effective for diabetic ketoacidosis?

This trial will compare early feeding with withholding oral intake for patients with diabetic ketoacidosis (DKA). Research has shown that early eating is safe for DKA patients. Studies have found that those who begin eating within the first 24 hours may spend less time in intensive care and the hospital. Early eating can help patients recover faster from DKA. Importantly, these studies found no increase in risk or negative effects from early eating. Overall, early eating appears to be a promising way to improve recovery times for DKA patients.14678

Who Is on the Research Team?

KK

Kenneth Kenneth, MD

Principal Investigator

Texas Tech University Health Science Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Early feedingExperimental Treatment1 Intervention
Group II: Nothing per mouthActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Texas Tech University Health Sciences Center

Lead Sponsor

Trials
107
Recruited
11,500+

Published Research Related to This Trial

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.
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]

Citations

Early vs late oral nutrition in patients with diabetic ...We found that oral feeding instituted in the first 24 h appeared safe and resulted in shorter intensive care unit and hospital lengths of stay.
Effects of the timing of the initiation of dietary intake on ...We conducted a retrospective study to investigate the effects of the timing of the initiation of dietary intake on DKA correction in Children's Hospital of ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40035917/
The effect of oral nutrition on diabetic ketoacidosis ...Conclusion: Oral nutrition until DKA resolves allows the patient to recover more quickly and have a shorter hospital stay. These findings suggest a relationship ...
Early Oral Rehydration Therapy in Diabetic KetoacidosisResults Both groups achieved successful correction of dehydration. No significant difference was observed in the time taken from randomization to complete ...
(PDF) Early vs late oral nutrition in patients with diabetic ...They reported that initiating nutrition early is safe and reduces ICU and hospital stays, and they showed no differences in mortality, DKA ...
Outcomes of Early vs Late Oral Nutrition in Patients With ...CONCLUSIONS: Oral nutrition in patients admitted to MICU for DKA initiated prior to the resolution of ketoacidosis appears safe and could potentially decrease ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30697371/
Early vs late oral nutrition in patients with diabetic ...In patients with DKA, early nutrition was associated with a shorter MICU and hospital LOS without increasing the rate of DKA complications.
Early vs late oral nutrition in patients with diabetic ...Outcomes included common complications of DKA, 28- and 90-d mortality, and length of ICU and hospital stay. Bivariate analysis was then ...
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