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Diabetic Ketoacidosis clinical trials

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NCT ID: NCT01753934 Completed - Diabetes Mellitus Clinical Trials

Diabetic Ketoacidosis and Its Impact on the Brain

Start date: May 2011
Phase:
Study type: Observational

About the Study: This research study is being conducted to see if diabetic ketoacidosis has any impact on learning, behavior and development in children with Type 1 diabetes mellitus. If there is an impact, is it transient or persistent? Sixty to 80 children between the ages of 4 to 17 years with Type 1 diabetes mellitus will have neuropsychological testing and a non-sedated MRI scan of the head performed. The investigators will compare this to a control group of 30-40 children between the ages of 4 to 17 years without Type 1 diabetes mellitus. The children with Type 1 diabetes mellitus will not have any changes made to their current diabetes regimen. The children with Type 1 diabetes mellitus should continue to check blood glucose values as required by your doctor and bring their meter(s) for downloading to each visit. The children with Type 1 diabetes mellitus should also tell your doctor about the frequency of severe low and high blood glucose values.

NCT ID: NCT01753921 Completed - Diabetes Clinical Trials

Evaluation of a Non-invasive Brain Compliance Measurement Device

Start date: November 2011
Phase:
Study type: Observational

This is a research study to understand how diabetic ketoacidosis may affect the brain and learning and to see if these changes are transient or permanent. The investigators hope to learn more about how diabetic ketoacidosis may cause changes in brain compliance (by wearing a non-invasive head band/helmet like device from Jan Medical: The Nautilus Neurowave Systemâ„¢ (NNS), learning, talking, behavior, or development. The investigators will compare those results from those with diabetes mellitus to those age and gendered matched healthy controls. Possible subjects in this study have diabetes mellitus and are between the ages of 10 to less than 17 years old OR do NOT have diabetes and are between the ages of 10 to less than 17 years old.

NCT ID: NCT01701557 Completed - Diabetes Clinical Trials

Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

Start date: November 2007
Phase: N/A
Study type: Interventional

Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment

NCT ID: NCT01477476 Withdrawn - Type I Diabetes Clinical Trials

Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes

Start date: March 2012
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled phase 2 study. Specific aim is to evaluate feasibility and safety of anti-IL-1 (interleukin 1) treatment in the course of standard therapy for diabetic ketoacidosis in children and its effect on intracranial pressure.

NCT ID: NCT01365793 Completed - Clinical trials for Diabetic Ketoacidosis

Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis

Start date: November 2010
Phase: Phase 3
Study type: Interventional

The investigators will conduct a randomized controlled trial comparing four different intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of these two basic rehydration protocols, the investigators will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). The investigators will compare the different treatments by conducting assessments of neurological injury, by measuring the frequency of significant cerebral edema, and by measuring long-term neurocognitive function. These studies will allow us to determine whether variations in IV fluid treatment protocols affect acute neurological outcomes of DKA. Additionally, they will provide important data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, the investigators hope to identify a more ideal fluid management strategy for children with DKA. Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and that brain injury might result from this reduction in blood flow and/or the effects of re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The investigators hypothesize that more rapidly re-establishing normal blood flow to the brain during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt) content, will help to minimize brain injury caused by DKA.

NCT ID: NCT00920725 Completed - Clinical trials for Diabetic Ketoacidosis

Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA

DKA
Start date: January 2005
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.

NCT ID: NCT00629707 Completed - Clinical trials for Diabetic Ketoacidosis

Cerebral Edema in Pediatric Diabetic Ketoacidosis

Start date: June 2008
Phase: N/A
Study type: Interventional

The purpose of this trial is to compare two different rates of fluid administration during diabetic ketoacidosis (DKA) treatment in children to determine which fluid administration rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling during DKA.

NCT ID: NCT00590044 Completed - Clinical trials for Diabetic Ketoacidosis

Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

Start date: December 2007
Phase: Phase 4
Study type: Interventional

The study is a multicenter, randomized controlled trial to compare the safety and efficacy of insulin analogs and human insulins both during acute intravenous treatment and during the transition to subcutaneous insulin in patients with diabetic ketoacidosis (DKA).

NCT ID: NCT00589680 Completed - Clinical trials for Diabetic Ketoacidosis

Compliance With American Diabetes Association Treatment Guidelines for Adult Ketoacidosis

Start date: December 2007
Phase:
Study type: Observational

At this time, Saint Mary's Medical Center is currently in the process of implementing a standardized diabetic ketoacidosis (DKA) protocol. The first main goal of this project will be to evaluate patient outcomes to determine the effects of treating patients without a standardized protocol and to establish a baseline on how patients are being treating with DKA. The final goal of the project will be to compare outcomes of those patients not placed on the protocol to those that were treated using SMMC newly implemented DKA protocol. The overall goal of this project is to determine the benefit of an institutional DKA protocol.

NCT ID: NCT00426413 Completed - Clinical trials for Diabetic Ketoacidosis

Ketosis Prone Diabetes in African-Americans

Start date: May 2007
Phase: N/A
Study type: Observational

Over 50% of obese African-Americans (AA) presenting with newly diagnosed, severe hyperglycemia and/or unprovoked diabetic ketoacidosis (DKA) display clinical, metabolic, and immunogenetic features of type 2 diabetes. Prior studies indicate that these patients a) have markedly decreased insulin secretion and impaired insulin action at presentation, b) absent or low prevalence of beta-cell autoantibodies and c) are able to discontinue aggressive insulin therapy in ~70% of cases within 3 months of follow-up. These patients have been referred to as having ketosis-prone type 2 diabetes (KPDM). Most patients with KPDM, however, experience a hyperglycemic relapse within a year of insulin discontinuation. Consequently, patients with "KPDM" are an ideal model to follow throughout their clinical course. The specific aims of this proposal are to 1) identify clinical, metabolic, and immunogenetic markers that alone, or in combination, are predictive of short- and long-term near-normoglycemic remission and 2) determine whether pioglitazone or sitagliptin therapy will delay an insulin-deficient relapse once insulin is discontinued. The Principal Investigator hypothesizes that measures of beta-cell function at presentation, alone or in combination with measures of insulin sensitivity, will correlate with the ability of a patient to achieve and remain in near-normoglycemic remission. She also hypothesizes that intervention compared to placebo will preserve beta-cell function, improve insulin sensitivity, and prevent an insulin-deficient relapse. This prospective, cohort study with a RCT arm would better characterize the natural history of KPDM, facilitate the direction of long-term therapy, and likely decrease the recurrence of DKA which is associated with increased mortality and morbidity.