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Hypoglycemia clinical trials

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NCT ID: NCT00804297 Completed - Diabetes Mellitus Clinical Trials

Octreotide for the Treatment of Sulfonylurea-Associated Hypoglycemia

Start date: June 2005
Phase: Phase 3
Study type: Interventional

Background: Hypoglycemia is a common presentation to the Emergency Department. Management has traditionally involved rapid administration of IV 50% dextrose and dextrose containing IV fluids in addition to oral carbohydrates. Hypoglycemic patients taking only insulin can often times be treated as outlined above and safely discharged to home after a period of short observation in the Emergency Department. This procedure is also followed in the pre-hospital care arena, where insulin-dependent hypoglycemic patients are often treated and released. In addition to diet-control and insulin, patients with diabetes maintain outpatient euglycemia with a class of drugs called sulfonylurea agents. This are believed to stimulate insulin release from pancreatic beta cells via a complex mechanism culminating in calcium influx and release of stored insulin from secretory granules within the pancreas. Whereas insulin-dependent diabetic patients are usually discharged home after establishing normal blood glucose levels, hospital admission is generally recommended in hypoglycemic patients taking oral sulfonylureas due to the long duration of effect and delayed clearance of the drugs and their metabolites and subsequent high likelihood of recurrent hypoglycemic episodes. Octreotide is a somatostatin analog that is known to suppress numerous hormones including insulin. Dextrose itself induces insulin secretion thus theoretically contributing to rebound hypoglycemia when used to treat hypoglycemia. Octreotide is thought to block the elevated insulin levels that are a result of both the sulfonlyureas and dextrose. Recent case reports and one prospective study in healthy volunteers have demonstrated the safety and efficacy of octreotide administration for the treatment of sulfonylurea induced hypoglycemia. Based largely on the results of these studies some experts in field of toxicology have argued that administration of octreotide be standard therapy for all patients with recurrent hypoglycemic episodes who are known to be taking sulfonylureas. Purpose: Measure the difference in serum glucose and the incidence of hypoglycemia between two groups of sulfonylurea-dependent patients; a control group that receives standard therapy and an experimental group that receives standard therapy plus octreotide.

NCT ID: NCT00802971 Completed - Hypoglycemia Clinical Trials

Idiopathic Reactive Hypoglycaemia and Treatment With Fructo-Oligosaccharide

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

Idiopathic reactive hypoglycemia (IRH) describes a condition where recurrent episodes of symptomatic hypoglycemia occurs one to four hours after a meal, usually following meals rich in carbohydrates. Differential diagnoses to be excluded include those caused by isulinomas or bariatric surgery (dumping syndrome), or iatrogenic induced hypoglycaemia. The prevalence of IRH is not fully known. A British trial among 1136 random chosen women aged 17-50, reported that 37.9% experienced symptomatic hypoglycemia four times every month (mean value). However, not all reported symptoms attributed to a low blood glucose (BG) correlates with measured low levels of BG and a "true" hypoglycaemic episode, i.e., as defined by American Diabetes Association (ADA) when plasma BG value is < 3,9 mmol/l with or without accompanying symptoms. This was underscored in three studies from England, Canada and Denmark, in whom all reported hypoglycaemic symptoms, but in whom accompanying plasma glucose values < 3,3 mmol/l during hypoglycaemic symptoms only occurred in 23, 47 and 0% of the study subjects, respectively. The majority of those with symptoms related to IRH hence are having these symptoms without being classified as hypoglycemic according to conventional interpretations. However, a new (2005) ADA definition; relative hypoglycemia, also comprise these symptomatic cases of hypoglycemia following a plasma glucose > 3,9 mmol/l. Hormonal and cerebral mechanisms tightly control the complex interplay of mechanisms involved in regulating BG concentration. Explanations for IRH are centralized around increased insulin secretion/sensitivity and/or down regulated transcription of glucagon receptor or reduced glucagons sensitivity- and secretion. Others assess an overabundance of adrenaline and cortisol, witch is excreted at the nadir of the BS curve (venous plasma glucose between 3.6 and 3.9). The latter event, during which typical symptoms is characterized of anxiety, fatigue, irritability, palpitations, nervousness, tachycardia, tremor and sweat. Today, treatment is limited to dietary recommendations of eating frequent meals of moderate size, reasonably high in protein, and with a low glycaemic load. These advices keep cerebral glucose concentration stable and prohibit neuroglycopenic symptoms like hunger, dizziness, tingling, blurred vision, difficulty in thinking, and faintness. Pharmacologic attempts in treating IRH involves diazoxide, metformin, α-glucosidase inhibitor, glitazones and somatostatin, however, none of these medications are specifically indicated for the condition. Fiber is a class of carbohydrate resistant to hydrolytic digestion in the upper bowel but fermented in the colon by bacterially produced enzymes. It makes the rate of ventricular emptying increase and prolongs the bowel transit time; thus having a minimal impact on BG values. Inulin and oligofructose are composed of polymers of oligofructose having characteristic features different from other fibers because of their physiological and biochemical attributes. Found in a variety of edible fruit and vegetables, their fermentation produces short-chain fatty acids that acidify the colonic content. This stimulates selectively the growth of beneficial and potentially health-promoting bifidobacteria and reduces potential harmful colon bacteria. Acting as prebiotica, oligofructose induces changes in the colonic epithelium and in miscellaneous colonic functions, inter alia, enhances calcium and magnesium absorption, modulates endocrine as well as immune functions and affects the metabolism of lipids positively. The latter, being at a systemic level, may contribute to modulating lipogenesis and reducing triglyceridemia by partially impairing hepatic cholesterol synthesis. FOS has not yet been investigated thoroughly as a possible stabilizer of blood glucose. However, several non-oligofructose studies, using a high-fiber diet, indicates reduced pre-prandial BG values, less hypoglycemic cases, glukosuri, total cholesterol, triglycerides, VLDL cholesterol and area under the curve (AUC) in a 24 hours measurement (every 2 hour) of BG and insulin concentration. Clinical evaluation of safety of inulin and oligofruktose as dietary fiber has reported 20 g/day of oligofructose to be well tolerated. The various GI side effects identified include abdominal pain and bloating, flatulence and osmotic diarrhea. Despite the fact that fiber intake is proven inversely related to hypoglycemic events, possible benefits of daily FOS-supplementation have not yet been investigated systematically in persons suffering of IRH. Given the estimated high prevalence of IRH it is in our aim to: 1. Study the prevalence and characteristics of subjects with IRH in a relevant Norwegian study population of 414 study participants. 2. Evaluating the effect of FOS supplementation on blood glucose variability.

NCT ID: NCT00798590 Enrolling by invitation - Hypoglycemia Clinical Trials

The Efficacy of GLP - 1(7-36) Amide for Glycemic Control in Critically Ill Patients

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

The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.

NCT ID: NCT00796848 Withdrawn - Diabetes Mellitus Clinical Trials

Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

Start date: March 2009
Phase: N/A
Study type: Interventional

The purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think that your body may not have enough of a certain hormone that usually helps people know when they are going low. If you can keep from going low, we think there will be enough of that hormone to help you recognize the symptoms of a low before it happens.

NCT ID: NCT00793741 Completed - Type 1 Diabetes Clinical Trials

Measurement of Glucose Metabolism in Humans Using Magnetic Resonance at 4 Tesla. Substudy: Hypoglycemia Unawareness

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

The purpose of this study is to determine whether islet transplantation alters brain glucose concentrations in patients with type 1 diabetes, recurrent hypoglycemia, and hypoglycemia unawareness when compared to that measured prior to transplant in the same subjects.

NCT ID: NCT00780650 Completed - Type 1 Diabetes Clinical Trials

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Start date: May 2009
Phase: Early Phase 1
Study type: Interventional

This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself against low blood sugar.

NCT ID: NCT00766441 Terminated - Diabetes Clinical Trials

Sitagliptin Versus Sulphonylurea in Type 2 Diabetes During Ramadan

Start date: August 2008
Phase: Phase 4
Study type: Interventional

This study will assess if Sitagliptin addition to metformin or glitazone is better than current sulphonylurea based treatments during Ramadan. The rationale is that Sitagliptin offers metabolic advantages primarily with the low incidence of hypoglycemia over current sulphonylurea based treatments.

NCT ID: NCT00745186 Completed - Hypoglycemia Clinical Trials

Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers

Start date: August 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamic bioequivalence and safety of Hospira Glucagon for Injection and GlucaGen® in healthy volunteers.

NCT ID: NCT00742521 Completed - Type 1 Diabetes Clinical Trials

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

Start date: March 2001
Phase: N/A
Study type: Interventional

It has been found that in some cases, when a person with Diabetes Mellitus has an episode of low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another bout of hypoglycemia during that exercise. The purpose of this study is to determine what factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia while exercising later.

NCT ID: NCT00734669 Completed - Type 2 Diabetes Clinical Trials

Risk of Hypoglycemia in Type 2 Diabetes

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

The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored via a continuous glucose monitoring system in a standardized clinical setting during day and night time, implementing meals and exercise of moderate intensity performed in the postprandial state.