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Hypoglycemia clinical trials

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NCT ID: NCT02829593 Completed - Healthy Clinical Trials

Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA

GABA
Start date: October 31, 2019
Phase: N/A
Study type: Interventional

You are invited to participate in a study designed to investigate the effects of diabetes mellitus, high and low glucose, and high blood insulin on the brain. You were selected as a possible participant because you fit into one of the following categories. a) you are either healthy and competent, are not pregnant and you have no known medical disease and therefore your glucose metabolism will be typical of a normal person, or b) you have diabetes.

NCT ID: NCT02778269 Completed - Diabetes Clinical Trials

Predicting Hypoglycaemia and Arrhythmias in the Patient With Diabetes and CKD - Validation Study

HypoArrhythmia
Start date: June 2016
Phase: N/A
Study type: Interventional

Patients with insulin-dependent diabetes mellitus (DM) and chronic kidney disease (CKD) exhibit an excessive risk for cardiac arrhythmias, in particular sudden cardiac death (SCD). Various studies have shown that hypoglycemic episodes are strong predictors of cardiovascular mortality in both type 1 and type 2 diabetic patients. Experimental data and small clinical studies link hypoglycemia with ECG changes and SCD, but little is known about the direct association of hypoglycemic events and/or rapid swings in blood glucose with arrhythmias in this high risk population. Ideally, an algorithm should help to identify patients at risk for hypoglycemia-associated arrhythmias and SCD, but hitherto systematic analyses of blood glucose values and 12-channel ECGs are lacking in these patients. In this validation study a 12-lead ECG T-shirt consisting of textile electrodes and a data logging device wich can record long-term 12-lead ECG data will be tested. The purpose of the T-shirt is to improve the patient's comfort for long-term recordings and to prevent adverse effects of regular ECG electrodes. Current systems are limited by the use of ECG electrodes involving disadvantages like severe direct side effects on the skin such as rash and bullous lesions as well as slipping electrodes. By the means of the proposed ECG T-shirt those drawbacks will be avoided.

NCT ID: NCT02772718 Completed - Hypoglycemia Clinical Trials

An Open-Label Study of XOMA 358 in Patients With Hypoglycemia After Gastric Bypass Surgery

XOMA 358
Start date: April 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and clinical pharmacology of XOMA 358 in patients with hypoglycemia after gastric bypass surgery.

NCT ID: NCT02771574 Completed - Clinical trials for Post Bariatric Hypoglycemia

Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia

Start date: May 2016
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia. Development of this subcutaneous formulation of exendin (9-39) would represent a targeted therapeutic approach for this rare disease with unmet clinical need.

NCT ID: NCT02747680 Completed - Healthy Clinical Trials

Cerebral Responses to Insulin Induced Hypoglycemia

1018
Start date: January 2004
Phase: N/A
Study type: Interventional

This research study is designed to investigate the effect of hypoglycemia (low blood sugar) on blood flow to and biochemistry in the brain.

NCT ID: NCT02735031 Completed - Clinical trials for Diabetes Mellitus, Type 1

Exenatide and Impaired Hypoglycaemic Awareness in Type 1 Diabetes

Start date: February 21, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

Approximately 25% of patients with type 1 diabetes have lost the capacity to timely detect hypoglycaemia, a condition referred to as impaired hypoglycaemic awareness (IHA) that causes a six-fold higher risk of severe, potentially hazardous, hypoglycaemia. IHA is usually the end-result of a process of habituation to recurrent hypoglycemia that is potentially reversible. Treatment with glucagon-like peptide (GLP)-1 Receptor Agonists (1RAs) in addition to insulin therapy may decrease the incidence of hypoglycaemia in patients with type 1 diabetes. This study will test the hypothesis that treatment with the GLP-1RA, exenatide, added to basal-bolus insulin therapy will improve awareness of hypoglycaemia in patients with type 1 diabetes and IHA. In a randomized doubleblind placebo-controlled cross-over trial, patients will be treated for 6 weeks with exenatide (or placebo), after which hypoglycemic symptoms and counterregulatory hormone responses will be examined during a hyperinsulinemic hypoglycemic glucose clamp study.

NCT ID: NCT02733588 Completed - Hypoglycemia Clinical Trials

Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients

Start date: March 2016
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe hypoglycemia following bariatric surgery.

NCT ID: NCT02714972 Completed - Type 1 Diabetes Clinical Trials

Reduction of Nocturnal Hypoglycemia and Hyperglycemia in the Home Using Predictive Algorithms, Pump Suspension, and Insulin Dosing in Children and Young Adolescents

PHM3
Start date: May 2016
Phase: Phase 2
Study type: Interventional

Objective: to gain experience in children and younger adolescents with in-home use of an algorithm that will dose insulin to minimize projected hyperglycemia overnight in addition to suspending the pump if hypoglycemia is projected overnight and to obtain feasibility, safety, and initial efficacy data Study Design: randomized controlled trial, with randomization on a night level within subject Patient Population: Youth 6.0 - <15 years old with type 1 diabetes treated with daily insulin therapy for at least one year and an insulin infusion pump for at least 6 months who have HbA1c < 10.0%. Sample Size: 30 subjects Study Duration and Visit Schedule: duration approximately 3 months, with preliminary run-in activities followed by up to 90 days spent in clinical trial phase of study; clinic visits at enrollment, following CGM and system assessment run-in phases, at start of clinical trial phase, at 21-day point of clinical trial phase, and after 42 nights of successful system use Major Efficacy Outcomes: - Primary: time in range (70-180 mg/dl, 3.9-10.0 mmol/L) overnight. - Secondary: time spent in hypoglycemia (<70 mg/dl, 3.9 mmol/L) and time spent in hyperglycemia (>180 mg/dl, 10.0 mmol/L) overnight. Major Safety Outcomes: CGM measures of hypo- and hyperglycemia, including morning blood glucose and mean overnight sensor glucose; adverse events including severe hypoglycemia and diabetic ketoacidosis

NCT ID: NCT02690168 Completed - Hypoglycemia Clinical Trials

Testing Glial Pathways to HAAF in Human Subjects Using Carbon 13 Magnetic Resonance Spectroscopy

GLIMpSE
Start date: February 2016
Phase:
Study type: Observational

Hypoglycemia-associated autonomic failure (HAAF), a condition commonly developed in diabetic patients, which causes them to have severely low blood sugar levels. This condition makes clinical management of blood sugar in diabetic patients very challenging. This research seeks to better understand how diabetic patients develop HAAF, and what can be done to prevent it.

NCT ID: NCT02687893 Completed - Hypoglycemia Clinical Trials

Effect of Hypoglycemia on Sleep

Start date: February 2016
Phase: N/A
Study type: Interventional

Growing evidence provided by many observational studies has established a strong link between decreased sleep duration and poor glucoregulation. Sleep deprivation and poor sleep quality induce insulin resistance and decrease glucose tolerance in healthy individuals. However, the influence of poor sleep quality on glycemic control of patients with Type 1 diabetes mellitus (T1DM) is unknown. Persistent sleep deprivation among patients with T1DM has been reported, and this sleep loss can be attributed in part to nocturnal hypoglycemia. Nocturnal iatrogenic hypoglycemia is a limitation of current intensive insulin therapies. Although severe hypoglycemia is associated with adverse events such as seizures and death, less severe nocturnal hypoglycemia has been linked to broad range of adverse consequences, both acutely and long term. Hypoglycemia stimulates the sympathetic nervous system as a stress response, leading to the stimulation of the hypothalamic-pituitary-adrenal axis (HPA). This results in a counter regulatory hormone cascade, which elicits an excessive cortisol secretion, which is known to cause sleep disturbance and could impair glucose homeostasis after the hypoglycemic event. The hyperinsulinemia in T1DM patients promotes HPA hyperactivity as well, which is also associated with impaired sleep quality by leading to sleep fragmentation, decreased slow wave sleep and shortened sleep duration. Sleep disturbances due to nocturnal hypoglycemia can exacerbate HPA axis dysfunction, adversely affecting the sleep-wake cycle. The goal of the study is to understand the impact of nocturnal hypoglycemia on sleep.