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Hypoglycemia clinical trials

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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: NCT05036317 Recruiting - Clinical trials for Postprandial Hypoglycemia

Empagliflozin for the Treatment of Postprandial Hypoglycemia

EmpHy
Start date: March 11, 2022
Phase: Phase 3
Study type: Interventional

This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.

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.

NCT ID: NCT05007977 Terminated - Type 1 Diabetes Clinical Trials

Effect of ZT-01 on Glucagon During Hypoglycemia in Type 1 Diabetes Mellitus

Start date: July 8, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether ZT-01 increases the glucagon response to hypoglycemia in type 1 diabetes (T1D). ZT-01 is a specific somatostatin (SST) type 2 receptor antagonist hypothesized to increase the counterregulatory glucagon release during hypoglycemia, which is impaired in diabetes, and may thus reduce the occurrence of hypoglycemia. Approximately 25 participants with well-controlled type 1 diabetes will be recruited to a crossover study and be randomized to the order in which they receive a single administration of placebo, low dose and high dose ZT-01 during three euglycemic-hypoglycemic clamps 2 to 6 weeks apart, with a follow-up visit approximately 1 week after the final clamp. Participants will stay overnight in the clinic before each clamp, and their plasma glucose (PG) will be kept at euglycemic levels with IV insulin and dextrose as needed. The following morning, the clamp will begin and the subject's PG will be kept at 5.5 mmol/L (euglycemia) with variable IV insulin (and dextrose as needed). Study treatment will be administered during this euglycemic period, and then insulin will be increased so that PG falls to a plateau of mild hypoglycemia, and then increased further to clinically significant hypoglycemia. Release of glucagon and other counterregulatory hormones will be measured, and a symptom score will be completed, during euglycemia before and following study treatment, and during each level of hypoglycemia. Following the clamp, the participant's blood glucose will be returned to normal levels prior to leaving the clinic.

NCT ID: NCT05004558 Not yet recruiting - Obesity Clinical Trials

Effects of Remote-based Resistance Training on Cardiometabolic Risk Factors, Cognitive Function, and Quality of Life in Adults Living With Alzheimer's Disease and/or Related Dementias

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The investigators aim to study the effects of a 24-week remote-based resistance exercise training program on cardiovascular disease risk factors, cognitive function, and quality of life in older adults living with mild cognitive impairment or Alzheimer's Disease and/or a related dementia. Data for this study will be collected at the beginning, middle, and end of the resistance training program. Participants of this study will receive a baseline health-fitness assessment at the beginning of the study. Measurements of resting blood pressure, fasting blood glucose and lipids, waist and hip circumferences, height and weight, cognitive function and quality of life will be collected at the health-fitness assessment. Participants will then receive supervised remote-based resistance exercise training with Therabands, 3 days per week for 12 weeks before receiving a second 12-week health-fitness assessment in the middle of the intervention. Participants will then receive 12 additional weeks of supervised remote-based resistance exercise training with Therabands, 3 days per week for 12 weeks before receiving a third 24-week health fitness assessment at the end of the study.

NCT ID: NCT04997460 Recruiting - Hypoglycemia Clinical Trials

Diabetes Type One in Pregnancy and Continuos Glucose Monitoring

DIP1/CRO
Start date: January 11, 2021
Phase:
Study type: Observational

Type I diabetes mellitus (T1DM) affects about 0.1-0.2% of all pregnancies. T1DM in pregnancy increases the risk of maternal and neonatal complications. Continuous glucose monitoring systems (CGM) provide a continuous display of measured glucose. Studies have shown improved pregnancy outcomes for patients with T1DM using CGM when compared to capillary blood glucose measurements. This prospective observational study analyses impact of glycemic variability on development of large-for-gestational-age neonates and effects of hypoglycemia during pregnancy on pregnancy outcomes. Furthermore, overall glycemic regulation, different insulin metrics and C-peptide concentration during pregnancy will also be assesed.

NCT ID: NCT04971070 Completed - Hypoglycemia Clinical Trials

Analysis of Related Risk Factors of Hypoglycemia Consciousness Disorder

Start date: July 25, 2021
Phase:
Study type: Observational

Objective to explore the high risk factors and inducements of consciousness disorder in patients with hypoglycemia, and to conduct a retrospective study.

NCT ID: NCT04942756 Active, not recruiting - Cancer Clinical Trials

GLYPALCARE STUDY - Multicenter, Randomized Study for Evaluating Continuous Glucose Monitoring (CGM) by Using FreeStyle Libre 2 (FSL2) for Preventing Hyperglycemia/Hypoglycemia Crisis in Advanced Oncological Patients.

Start date: June 30, 2021
Phase: N/A
Study type: Interventional

Cancer patients with known or newly diagnosed (i.e. iatrogenic) Diabetes Mellitus (DM) in Palliative/Supportive Care will be enrolled. Patients will be randomly assigned to one of two groups. Patients included in the first group will monitor glucose levels through Continuous Glucose Monitoring (CGM), using the FreeStyle Libre 2 (FSL2). The second group is represented by the usual standard way for blood glucose (BG) monitoring (lancing device for finger samples). An interim analysis is foreseen when the half of the expected events (hyperglycemic peaks) will be observed. In case the results of interim analysis show superiority of the CGM (FSL2) group patients of the second group will be switched.