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Ketosis clinical trials

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NCT ID: NCT02864914 Completed - Clinical trials for Diabetes Mellitus, Type 2

Post-authorisation Safety Study in Patients With Type 2 Diabetes to Assess the Risk of Liver Injury, Kidney Injury, Urinary Tract and Genital Infections, and Diabetic Ketoacidosis in Patients Treated With Empagliflozin, Compared to DPP-4 Inhibitors

Start date: March 15, 2016
Phase:
Study type: Observational

Empagliflozin (Jardiance), a highly potent and selective inhibitor of the sodium-glucose cotransporter 2 (SGLT2), was approved in Europe in May 2014 for the treatment of type 2 diabetes mellitus (T2DM) to improve glycaemic control in adults. As part of the risk management plan, Boehringer Ingelheim International GmbH (BI) has committed to conduct a post-authorisation safety study (PASS) to evaluate the liver and renal safety of empagliflozin. The study will also evaluate the risks of severe complications of urinary tract infections (UTIs) and genital infections. To evaluate the association between empagliflozin use and mentioned outcomes routinely collected health information from the Clinical Practice Research Datalink (CPRD), the Hospital Episodes Statistics, and Office of National Statistic will be used. This PASS will be conducted through an observational cohort study among adult patients with T2DM and at least 12 months of continuous enrolment in the CPRD where new users of empagliflozin will be compared to new users of dipeptidyl peptidase-4 (DPP4) inhibitors. Estimations will be made on the crude and adjusted incidence rates and adjusted incidence rate ratios of the primary and secondary outcomes.

NCT ID: NCT02636192 Completed - Clinical trials for Diabetes Mellitus, Type 2

Study on Incidence of Diabetic Ketoacidosis Among Participants With Type 2 Diabetes Mellitus Treated With Sodium-glucose Co-transporter 2 (SGLT2) Inhibitors or Other Antihyperglycemic Agents

Start date: July 31, 2015
Phase: N/A
Study type: Observational

The purpose of this study is to compare the incidence of diabetic ketoacidosis (DKA) among participants diagnosed with type 2 diabetes mellitus (T2DM) and pair-matched on exposure propensity scores for new use of any sodium-glucose co-transporter 2 inhibitors (SGLT2i) versus new use of various other antihyperglycemic agents (AHAs), combined as one group.

NCT ID: NCT02524002 Completed - Ketosis Clinical Trials

Enhanced vs. Routine Clear Liquid Intake in Labor

Start date: August 2014
Phase: N/A
Study type: Interventional

The goal of the study is to see if the addition of a carbohydrate- and protein-enhanced gel during labor speeds labor and reduces the rate of cesarean delivery.

NCT ID: NCT02443415 Completed - Clinical trials for Diabetic Ketoacidosis

Diabetic Ketoacidosis: Brain Morphology and Cognition

DKA-Cog
Start date: February 2015
Phase: N/A
Study type: Observational

The purpose of this study is to assess brain and memory changes in patients with uncontrolled diabetes (a condition called diabetic ketoacidosis (DKA))

NCT ID: NCT02172092 Completed - Diabetes Clinical Trials

Fluid Kinetics in Patients With Diabetic Ketoacidosis

FDKA
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose with the study is to follow the fluid shifts that occur during fluid resuscitation of patients with diabetic ketoacidosis. In the study measurements of changes in blood and urine concentrations of Sodium and Chloride as well as blood hemoglobin are used to mathematically calculate changes in distribution volumes of these different endogenous markers.

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 System™ (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: 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: NCT01110005 Completed - Ketosis Clinical Trials

A Trial of Intravenous Fluids During Labor

RARHY
Start date: April 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if intrapartum use of a glucose-containing solution will improve the outcomes in pregnant women and their babies.

NCT ID: NCT01099618 Completed - Hyperglycemia Clinical Trials

Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment

Start date: March 2010
Phase: Phase 4
Study type: Interventional

The study intends on enrolling 48 subjects with diabetes. Diabetic subjects that no longer need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active medication). Subjects on pills will be followed for 3½ years and undergo blood tests at specified intervals to assess their ability to make insulin. These studies will allow a better understanding of the factors that lead to high blood sugar in patients with ketosis-prone diabetes mellitus (KPDM) and direct the best diabetes treatment for this patient population. Hypothesis: Metformin therapy or sitagliptin therapy compared to placebo, will improve β-cell function, insulin sensitivity, and allow for a longer period of time prior to encountering an insulin-deficient relapse after discontinuation of insulin therapy.