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Hypoglycemia clinical trials

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NCT ID: NCT00706693 Completed - Clinical trials for Type 1 Diabetes Mellitus

Skittles(TM) Effective for Treating Hypoglycemia in Children With Type 1 Diabetes

Start date: August 2003
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the most effective treatment option for managing naturally occurring hypoglycemia in children with type 1 diabetes. Hypotheses: 1. Sucrose and Fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes. 2. Children and teens will use a variety of treatment practices for the management of hypoglycemia. 3. Children and teens will prefer the mode of treatment that was most effective in treating hypoglycemia.

NCT ID: NCT00678145 Active, not recruiting - Diabetes Mellitus Clinical Trials

Mechanisms of Hypoglycemia Associated Autonomic Failure

Start date: March 2008
Phase: Phase 2
Study type: Interventional

Intensive glucose control in type 1 diabetes mellitus (T1DM) is associated with clear health benefits (1). However, despite development of insulin analogs, pump/multi-dose treatment and continuous glucose monitoring, maintaining near-normal glycemia remains an elusive goal for most patients, in large part owing to the risk of hypoglycemia. T1DM patients are susceptible to hypoglycemia due to defective counterregulatory responses (CR) characterized by: 1) deficient glucagon release during impending/early hypoglycemia; 2) additional hypoglycemia-associated autonomic failure (HAAF) and exercise-associated autonomic failure (EAAF) that blunt the sympathoadrenal responses to hypoglycemia following repeated episodes of hypoglycemia or exercise as well as degrading other CR; and 3) hypoglycemia unawareness (HU), lowering the threshold for symptoms that trigger behavioral responses (e.g. eating). Thus, the risk of hypoglycemia in T1DM impedes ideal insulin treatment and leads to defaulting to suboptimal glycemic control (2). There are two approaches that could resolve this important clinical problem: 1) perfection of glucose sensing and insulin and glucagon delivery approaches (bioengineered or cell-based) that mimic normal islet function and precisely regulate glucose continuously, or 2) a drug to enhance or normalize the pattern of CR to hypoglycemia. Despite much research and important advances in the field, neither islet transplantation nor biosensor devices have emerged as viable long-term solutions for the majority of patients (3, 4). Over the past several years, our lab has explored the approach of enhancing CR by examining mechanisms responsible for HAAF/EAAF and searching for potential pharmacological methods to modulate the CR to hypoglycemia (5-11). Our work has led to a paradigm shift in the field of hypoglycemia, exemplified by the novel hypothesis and published experimental data supporting a role for opioid signaling that resulted in the initiation of exploratory clinical trials by other research groups.

NCT ID: NCT00674440 Completed - Hyperinsulinism Clinical Trials

Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Start date: December 2004
Phase: Phase 2
Study type: Interventional

Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug (called F-DOPA) can detect a form of hyperinsulinism that may be cured by surgery. Eligible participants in this study will have positron emission tomography (PET) scans with F-DOPA prior to surgery.

NCT ID: NCT00672204 Terminated - Clinical trials for Type 1 Diabetes Mellitus

Raptiva and Sirolimus in Islet Transplantation for Type 1 Diabetes

RAPTIVA
Start date: November 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this protocol is to test the safety and efficacy of a treatment regimen consisting of maintenance therapy with efalizumab and sirolimus for 1 year followed by withdrawal of efalizumab and maintenance therapy with sirolimus, for the prevention of the destruction and rejection of islet transplants in type 1 diabetic recipients. Genentech, the manufacturer of efalizumab voluntarily withdrew the drug from the U.S. market in April of 2009. Previously transplanted subjects have been transitioned to alternative immunosuppressives and no new subjects will be transplanted under this protocol.

NCT ID: NCT00662922 Completed - Critical Illness Clinical Trials

Consequences of Hypoglycemia on Intensive Care Unit (ICU) Patients

Start date: April 2008
Phase: N/A
Study type: Observational

Hypoglycemia occurs frequently during intensive blood glucose control in critically ill patients. The incidence of hypoglycaemia is associated with impaired outcome. However, it is hitherto unknown if hypoglycaemia itself predisposes patients to neurological impairment, e.g. cognitive dysfunction, or if it is the underlying medical condition that makes the patient prone to a high risk of hypoglycaemia and, concomitantly, neurocognitive impairment. Therefore we investigate neurocognitive function in patients who had hypoglycemias during their intensive care stay and compare the results to patients without hypoglycaemia whose medical conditions are matched to the hypoglycaemia patients.

NCT ID: NCT00643110 Withdrawn - Type 1 Diabetes Clinical Trials

Milk as Treatment for Hypoglycemia

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

Test hypothesis that milk can raise blood sugars as well as orange juice or glucose tablets without raising blood sugars too much the way that orange juice or glucose tablets sometimes do.

NCT ID: NCT00641407 Completed - Clinical trials for Type 2 Diabetes Mellitus

Bedtime Insulins and Oral Antihyperglycemic Drugs in Type 2 Diabetes

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

The maintenance of nearly normal glycemic levels reduces the risk of diabetic complications, but is difficult to achieve, despite the administration of escalating doses of oral antidiabetic drugs, such as metformin, sulfonylureas, and thiazolidinediones. Most patients eventually require insulin which usually is added when glycemic control with a regimen of oral antidiabetic agents becomes suboptimal. The aims of the present study were: 1) To compare the clinical efficacy of insulin glargine and neutral protamine lispro (NPL) insulin when added to ongoing oral therapy in poorly controlled type 2 diabetic patients; 2) to find out the possibility to phenotype the patient who may benefit more by the single treatment. This an open-label, randomized, parallel, 36-week comparative study was performed between January 2007 and March 2008 at a single centre.

NCT ID: NCT00615368 Completed - Type 1 Diabetes Clinical Trials

Treatment With Erythropoietin and Cognition During Hypoglycaemia

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

The purpose of the trial is to determine if erythropoietin (EPO) can enhance cognitive function during hypoglycaemia in patients with type 1 diabetes. Patients with type 1 diabetes will receive one injection of EPO. Hypoglycaemia will be induced 6 days after. Before (1 hour), during and after (1 hour) hypoglycaemia, the cognitive function will be measured.

NCT ID: NCT00614094 Completed - Clinical trials for Maternal Hypoglycemia

Maternal Hypoglycemia and Placental Pathology

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

The purpose of this retrospective pilot study is to assess the association of maternal hypoglycemia during the one hour glucose tolerance test with decreased placental weight and identifiable placental pathology. We hypothesize that a decreased one hour glucose tolerance test is a risk factor for decreased placental weight, an increased fetal to placental weight ratio, and other identifiable placental pathology.

NCT ID: NCT00609895 Completed - Diabetes Mellitus Clinical Trials

The Incidence of Hypoglycemia in Insulin Glargine-Treated Subjects With Diabetes Mellitus Upon Switching Between Bedtime and Morning Dosing

Start date: January 2004
Phase: Phase 4
Study type: Interventional

To compare the percentage of subjects with a glucose measurement < than or = to 56 mg/dL at any point of the 8-point glucose profiles during 3 consecutive days before vs. 3 consecutive days after switching insulin glargine dosing time from bedtime to morning and vs. 3 consecutive days after switching back to bedtime dosing of insulin glargine.