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Early feeding for Diabetes

N/A

Waitlist Available

Led By Kenneth Kenneth, MD

Research Sponsored by Texas Tech University Health Sciences Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admission to the Medical Intensive Care Unit

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days (typically 3-5 days in the micu, may be up to 1 week).

Awards & highlights

Study Summary

This trial aims to study the effects of providing food early on during the treatment of diabetic ketoacidosis (DKA), a serious metabolic disorder commonly seen in intensive care. Currently, it is common practice

Who is the study for?

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).Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves the initiation of an oral diet rather than a medication or procedure, side effects may include typical digestive issues but will largely depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am admitted to the ICU for serious medical issues.

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I have been diagnosed with diabetic ketoacidosis.

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I am between 18 and 89 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-7 days, may be up to 1-2 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-7 days, may be up to 1-2 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-7 days, may be up to 1-2 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of stay in the medical intensive care unit (in days).

Resolution of DKA

Secondary outcome measures

Length of stay in the hospital

mortality

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early feedingExperimental Treatment1 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 mouthActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Texas Tech University Health Sciences CenterLead Sponsor

104 Previous Clinical Trials

10,574 Total Patients Enrolled

Kenneth Kenneth, MDPrincipal InvestigatorTexas Tech University Health Science Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this clinical trial?

"Patients between the ages of 18 and 89 who have been diagnosed with diabetes are eligible for this clinical trial. A total of 200 patients will be enrolled in the study."

Answered by AI

Is the current clinical trial open for patient enrollment at this time?

"According to the current information available on clinicaltrials.gov, this particular study is not actively seeking participants. The trial was initially posted on December 27th, 2023 and most recently updated on January 3rd, 2024. However, it's worth noting that there are currently 1137 other ongoing clinical trials that are actively recruiting individuals at this time."

Answered by AI

Is the clinical trial open to individuals who are above 60 years old?

"To be eligible for participation in this clinical trial, applicants must fall within the age range of 18 to 89 years. It is worth noting that there are a total of 172 trials available exclusively for individuals below the age of 18 and an additional 863 trials specifically targeting patients over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Starvation in the Treatment of Diabetic Ketoacidosis

2023. "Starvation in the Treatment of Diabetic Ketoacidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06186245.