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Hypoglycemia clinical trials

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NCT ID: NCT05250271 Completed - Clinical trials for Roux-en-Y Gastric Bypass

Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 2

PBH Forecast
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

The overall aim of this study is to develop a sustainable hypoglycemia correction strategy.

NCT ID: NCT05216926 Completed - Clinical trials for Roux-en-Y Gastric Bypass

Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 3

PBH Forecast
Start date: January 18, 2022
Phase: N/A
Study type: Interventional

The overall aim of this study is to prevent hypoglycemic events in patients with hypoglycemia after a meal and to develop a sustainable hypoglycemia correction strategy.

NCT ID: NCT05212207 Completed - Clinical trials for Roux-en-Y Gastric Bypass

Forecasting and Preventing Post-Bariatric Hypoglycaemia WP 1

PBH Forecast
Start date: January 18, 2022
Phase:
Study type: Observational

The overall aim of this study is to prevent hypoglycemic events in patients with hypoglycemia after a meal and to develop a sustainable hypoglycemia correction strategy.

NCT ID: NCT05183191 Completed - Diabetes Clinical Trials

The HEADWIND Study - Part 3

Start date: November 29, 2021
Phase: N/A
Study type: Interventional

To analyse driving behavior of individuals with type 1 diabetes in eu- and mild hypoglycaemia using a validated research driving simulator. Based on the driving variables provided by the simulator the investigators aim at establishing algorithms capable of discriminating eu- and hypoglycemic driving patterns using machine learning classifiers.

NCT ID: NCT05171751 Completed - Clinical trials for Octreotide Adverse Reaction

Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia

BCH
Start date: November 1, 2021
Phase:
Study type: Observational

To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.

NCT ID: NCT05133765 Completed - Hypoglycemia Clinical Trials

The SMART B Exercise Study :''The SMART Study''

SMART
Start date: September 14, 2021
Phase: N/A
Study type: Interventional

Despite the established health benefits conveyed by physical activity for people with type 1 diabetes (T1D), participation rates remain low, with fear of hypoglycaemia, lack of freedom to engage in unplanned activities, and uncertainty in making appropriate adjustments to insulin and nutritional therapy reported as the leading barriers to regular exercise engagement. Indeed, the synergistic glucose lowering effects of peripheral hyperinsulinaemia and exercising muscle tissue accentuate the risk of exercise-related hypoglycaemia for individuals with T1D, particularly if performed post-prandially. Hence, the introduction of commercially available artificial pancreas systems, also known as ''advanced hybrid-closed-loop'' (AHCL) systems, that regulate insulin rates with minimal user interaction constitute compelling therapeutic aids with clinically relevant potential. Nevertheless, we know little about their safe and efficacious integration around dynamic physical exercise. Nor do we know how alterations in carbohydrate fueling strategies around exercise effect subsequent glucose trends. This study aims to 1) compare the efficacy of an AHCL system versus usual care insulin pump therapy, with carbohydrates taken before or during exercise, in optimising TIR around dynamic physical exercise and 2) explore the influence of carbohydrate intake before versus during exercise on the metabolomic, hormonal and physiological responses to exercise.

NCT ID: NCT05076292 Completed - Type 1 Diabetes Clinical Trials

Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

Start date: November 23, 2021
Phase: N/A
Study type: Interventional

The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI). The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and outpatient settings.

NCT ID: NCT05057819 Completed - Dumping Syndrome Clinical Trials

Investigating the Impact of the SGLT2 Inhibitor Empagliflozin on Postprandial Hypoglycaemia After Gastric Bypass

Start date: December 1, 2021
Phase: Phase 4
Study type: Interventional

Bariatric surgery is an effective anti-obesity treatment providing durable weight loss and profound beneficial effects on glucose metabolism. However, bariatric surgery also comes with an increased risk for a late metabolic complication known as postbariatric hypoglycaemia (PBH). The condition presents with hypoglycaemic episodes 1-3 hours after meals and develops one to several years after bariatric surgery, mainly gastric bypass. PBH affects approximately 30% of patients without preexisting diabetes. For a subset of patients, hypoglycaemia-associated impairment of daily living and social functioning are commonly observed. The underlying mechanisms of PBH are multifactorial. It is considered that inadequately high insulin secretion caused by both accelerated glucose absorption from the gut and increased insulinotropic hormones such as GLP-1 are important pathophysiologic mechanisms. Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor reduces glucose exposure by increasing urinary glucose excretion. In a pilot study, a single dose of 10mg of empagliflozin taken before a mixed meal reduced the risk of PBH by 74%. Both, postprandial glucose and insulin exposure were significantly lower with empagliflozin vs. placebo, which makes Empagliflozin a potential treatment for PBH. In this study, treatment naïve patients will be randomized to receive either oral empagliflozin 25 mg daily in the morning for 20 days, followed by 2-6 weeks wash out and 20 days placebo once daily in the morning, or the reverse sequence. Urine and blood analysis will be performed as detailed in the protocol.

NCT ID: NCT05022433 Completed - Clinical trials for Very Low Birth Weight Infant

Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates

Start date: June 6, 2019
Phase:
Study type: Observational

Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a suitable method for parenteral nutrition access and medications administration. Despite the benefits of the UVC, its potential complications must be considered. Thus, it is vital to determine the appropriate penetration length of the UVC.

NCT ID: NCT05011682 Completed - Obesity, Morbid Clinical Trials

The Effect of 'Medical Nutrition Therapy' on Post-bariatric Hypoglycemia 2-4 Years After Gastric Bypass Surgery

Start date: August 27, 2021
Phase: N/A
Study type: Interventional

This is a pilot study to explore the effect of 'medical nutritional therapy' in patients diagnosed with post-bariatric hypoglycemia (PBH), 2-4 years after gastric bypass surgery. The study is largely inspired by the findings presented in the meta-analyses from Joslin Diabetes Center, where a treatment strategy is proposed to reduce the symptoms of PBH. This treatment strategy is mainly based on clinical observations and experience, while there is little or no objective data to support that this strategy improves PBH. The data from this pilot study can then be used to set up larger studies where a conclusion on treatment of PBH may be drawn.