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Hypoglycemia clinical trials

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NCT ID: NCT00434772 Completed - Hypoglycemia Clinical Trials

Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth. After birth, glucose and ketone bodies are the main substrates of brain energy. Under normal condition, the adrenergic response seen immediately after birth suppresses insulin release and stimulates glucagon secretion which enhances gluconeogenesis and ketogenesis. An inversion of the insulin/glucagon ratio is seen soon after birth as a normal, physiologic phenomenon. Consequently, a post delivery glucose nadir is reached between 30 to 90 minutes after birth, followed by a spontaneous recovery before 3-4 hours of age. In infants of diabetic mothers, this inversion of the ratio is postponed and a more profound and sustained hypoglycemia is seen. Early feeding is of great importance to diminish the severity and incidence of hypoglycemia. But, if despite an appropriate calorie intake, low levels of sugar are seen, an intravenous infusion of glucose should be commenced. In case that IV glucose is not effective or can't be supplied immediately, intramuscular glucagon is a therapeutic alternative. We hypothesize that a single intramuscular injection of glucagon together with the appropriate oral intake of nutrients is a safe and an effective alternative to the IV infusion of glucose alone in the treatment of hypoglycemia in term infants of diabetic mothers. Methods Appropriately grown or large for date, term infants of insulin treated diabetic mothers, with no other known medical problems, are potential candidates for our study. Hypoglycemia will be defined as serum glucose level lower than 45 mg%. Infants of diabetic mothers will arrive to the nursery and immediately receive early feeding before 30 minutes of life. At that time, glucose will be checked. If glucose level is lower than 45 mg%, treatment with IV glucose or IM glucagon will be initiated. Glucose will be checked every hour for 4 hours and then every 3 hours (before each meal) for the next 20 hours. In case blood glucose level is lower than 20 mg% or falls below 45 mg% despite glucagon treatment, IV glucose will immediately be instituted. Our aim is to check that IM Glucagon is as good as IV glucose in the treatment of hypoglycemia in infants of diabetic mothers. We will compare glucose levels after treatment with IV glucose and IM glucagon, the time till normalization of glucose and full feeding is achieved and the number of hospitalization days in both groups.

NCT ID: NCT00418288 Completed - Stroke Clinical Trials

The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia

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

Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New animal studies indicate a protective effect of GLP-1 in the brain and the heart. The mechanism behind this is yet not known. The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert protective effects in the brain.

NCT ID: NCT00390728 Completed - Clinical trials for Diabetes Mellitus, Type 1

Insulin Glargine in Type I Diabetes Mellitus> Main Study "AT.LANTUS": A Trial Comparing Lantus Algorithms to Achieve Normal Blood Glucose Targets in Subjects With Uncontrolled Blood Sugar. Sub-study: "HALT"(Hypoglycaemia Avoidance With Lantus Trial)

AT-LANTUS
Start date: April 2002
Phase: Phase 4
Study type: Interventional

Primary objective: AT.LANTUS main study* - To determine the optimal treatment algorithm for insulin glargine based on the incidence of severe hypoglycaemia.(*Target Number of patients for the main study:2346) HALT Sub-study** - To test the hypothesis that titration regimens involving insulin glargine are associated with changes in the rate of symptomatic hypoglycaemic episodes together with changes in Fear of Hypoglycaemia as measured by the HFS-98 Questionnaire in Type I diabetes.(**Target Number of patients for the Sub-study: 250) Secondary objectives: AT.LANTUS main study To determine: - the incidence of symptomatic, asymptomatic and nocturnal hypoglycaemia with each treatment regimen - the difference in glycemic control as measured by HbA1c and fasting blood glucose with each treatment regimen - the difference in glycemic control as measured by HbA1c and fasting blood glucose between baseline and end of treatment - the safety on the use of insulin glargine in each treatment algorithm - the change in subject weight with each treatment regimen - the change in insulin doses with each treatment regimen - the change in Diabetes Treatment Satisfaction (Diabetes Treatment Satisfaction Questionnaire, sub-study only) with each treatment regimen HALT Sub-study (baseline to study end) - To estimate the relationship between change in HbA1c and incidence of hypoglycaemia - To examine the effect of insulin glargine on Quality of Life (EQ-5D) in relation to incidence of hypoglycaemia - To examine the effect of insulin glargine on the Hospital Anxiety and Depression Scale (HADS) in relation to the incidence of hypoglycaemia - To examine the use of the Prescription Plan versus standard management (no Prescription Plan)

NCT ID: NCT00373854 Completed - Hypoglycemia Clinical Trials

Study of How Low Blood Sugar Affects the Way Blood Vessels Work

Start date: September 2005
Phase: N/A
Study type: Observational

Hypothesis: Low blood sugar (hypoglycemia) decreases function of the lining of the blood vessels in normal humans. This study is designed to explore how hypoglycemia affects the function of the blood vessel lining. This will be determined by measuring blood flow to the arm before and after occlusion of flow. Blood vessel function will be measured before induction of hypoglycemia, during insulin induced hypoglycemia, and after recovery from hypoglycemia. A second study will be done but without hypoglycemia.

NCT ID: NCT00361608 Withdrawn - Type I Diabetes Clinical Trials

Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device

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

This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.

NCT ID: NCT00360984 Completed - Clinical trials for Type 1 Diabetes Mellitus

Prevention of Severe Hypoglycemia in Type 1 Diabetes

Start date: May 2003
Phase: Phase 4
Study type: Interventional

Severe hypoglycaemia leading to collapse without warning is one of the most-feared complications for those with Type 1 diabetes. The aim of this study is to determine whether detection and targeted prevention of hypoglycaemia by using either an optimised subcutaneous insulin regime or continuous insulin regime can restore hypoglycaemia awareness in Type 1 diabetes. Following a 6-day continuous subcutaneous monitor glucose profile, participants will be randomised to 1 of 3 interventions: rigorous avoidance of hypoglycaemia on current insulin regime; targeted optimisation of subcutaneous insulin regime to avoid hypoglycaemia; or continuous subcutaneous insulin infusion. Symptomatic experience and severity of hypoglycaemia, pattern of hypoglycaemia on glucose profiling and, in selected individuals, response to hyperinsulinaemic hypoglycaemic clamp, will be compared over a 6 month period. It is envisaged that successful prevention of hypoglycaemia by one or more interventions may reverse altered hypoglycaemia awareness and prevent further episodes of severe hypoglycaemia.

NCT ID: NCT00351234 Completed - Hypoglycemia Clinical Trials

Carnitine Levels and Carnitine Supplementation in Type I Diabetes

Start date: October 2004
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether type I diabetics with carnitine deficiency exhibit increased numbers of hypoglycemic (low blood sugars) events and if unrecognized hypoglycemia occurs during continuous 72-hour glucose monitoring. If they are determined to have unrecognized hypoglycemia, then oral carnitine supplementation will be given to those subjects and they will be reassessed for the number of hypoglycemic events in a 72-hour glucose monitoring.

NCT ID: NCT00346996 Completed - Type 1 Diabetes Clinical Trials

Insulin Analogues and Severe Hypoglycaemia

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

Severe hypoglycaemia is hampering the lives of many diabetic patients. The effect on the occurrence of severe hypoglycaemia during two different insulin regimens are to be investigated. In total, 250 hypoglycaemia prone type 1 diabetic patients will be randomised to receive analogue and human insulin for one year in random order. Outcomes will be number of episodes of severe hypoglycaemia

NCT ID: NCT00332449 Recruiting - Clinical trials for Neonatal Hypoglycemia

Early Breast Feeding and Glucose Levels in High Risk Newborns

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

Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.

NCT ID: NCT00322660 Completed - Hypoglycemia Clinical Trials

Adrenaline Injections to Children Born at Elective CS

Start date: June 2006
Phase: N/A
Study type: Interventional

Children born after elective C-section have a greater risk of respiratory problems and hypoglycemia - most likely due to a lower concentration of stress hormones compared to children born vaginally. Hypothesis: can we eliminate or reduce the risk of respiratory distress and hypoglycaemia by administrating adrenaline to the newborn.