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Hypoglycemia clinical trials

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NCT ID: NCT04841304 Active, not recruiting - Diabetes Mellitus Clinical Trials

Cardiac Arrhythmia in Patients With End-Stage Renal Disease

CADDY
Start date: June 1, 2021
Phase:
Study type: Observational

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure. The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes. Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.

NCT ID: NCT04614168 Active, not recruiting - Type 1 Diabetes Clinical Trials

Maximising Time With a Normal Blood Glucose to Restore the Glucagon Response in Type 1 Diabetes

Start date: July 26, 2021
Phase: N/A
Study type: Interventional

Almost all people who have had type 1 diabetes for 5 years have a defect in secretion of the hormone Glucagon. This hormone is involved in the body's response to low blood glucose (hypoglycaemia). It works by releasing glucose stores from the liver to bring the blood glucose back to normal. This defect therefore increases the risk of severe hypoglycaemia. The reason for this Glucagon defect in people with Type 1 diabetes is currently unknown. This study aims to look at the Glucagon response to hypoglycaemia in 24 people with type 1 diabetes to ascertain whether tight blood glucose control over a period of time improves this response. The investigators aim to achieve good blood glucose control using new generation Automated Insulin Delivery systems (AIDs). This system is made of: an insulin pump, a continuous glucose monitor (CGM) and an algorithm that allows adjustment of insulin delivery based on the blood glucose readings from the CGM. This is the most up to date technology that there is in the management of type 1 diabetes. However, people using this technology often still have problems with high blood glucose after eating. To ensure a very good blood glucose control participants will also follow a low carbohydrate diet to prevent this blood glucose rise after meals. The Glucagon response to low blood glucose will be measured at zero and eight months using the hyperinsulinaemic hypoglycaemic clamp technique.

NCT ID: NCT04585191 Active, not recruiting - Hypoglycemia Clinical Trials

Reducing Treatment Risk in Older Adults With Diabetes

RETRO-DM
Start date: November 2, 2020
Phase: N/A
Study type: Interventional

This study will evaluate the impact of academic detailing (evidence-based provider education) with or without patient pre-visit preparation (elicitation of values and preferences) on safe insulin de-prescribing among older patients with type 2 diabetes at risk for hypoglycemia. The hypothesis is that patients who are well-prepared for their primary care visit will engage in more informed discussions with their providers regarding re-evaluation of current treatment regimens. In clinically appropriate cases, these more effective discussions will result in safe de-prescribing and fewer future episodes of hypoglycemia.

NCT ID: NCT04432090 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

Study of the Pharmacologic Action of a GPR119 Agonist on Glucagon Counter-regulation During Insulin-induced Hypoglycemia in Type 1 Diabetes Mellitus

PHROG
Start date: April 21, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to test if a specific research medication could increase the response to low blood glucose in people with type 1 diabetes. The response of the body to low blood sugar will be measured in healthy people as a reference point.

NCT ID: NCT04430582 Active, not recruiting - Hypoglycemia Clinical Trials

Cognition in Patients With Hypoglycemia, Without Diabetes

Start date: August 4, 2020
Phase:
Study type: Observational

The purpose of this study is to determine if there is a relationship between recurrent hypoglycemia (low blood sugar) and cognition (thinking) in individuals who have a history of hypoglycemia, but do not have pre-diabetes or diabetes. This study will analyze whether recurrent hypoglycemia is associated with differences in cognition (thinking), and if individuals with a history of hypoglycemia perform less well on cognitive assessments compared to individuals without known hypoglycemia.

NCT ID: NCT04428866 Active, not recruiting - Hypoglycemia Clinical Trials

Mechanisms of Post-Bariatric Hypoglycemia

Start date: February 26, 2020
Phase:
Study type: Observational

Post-bariatric hypoglycemia (PBH) is an increasingly recognized syndrome that is incompletely understood. The purpose of this study is to increase our level of understanding by investigating mechanisms contributing to this condition. Participation in this study will take place over four visits, which will include the following: - Wearing of a continuous glucose monitoring device; - Providing a stool sample (collected at home); - Measuring glucose and hormone levels in response to a meal; - Measuring glucose and hormone levels in response to an injection of glucagon; - Measuring hormone levels while glucose levels are gradually lowered, and during a controlled period of a low glucose level (hypoglycemic clamp). Investigators will test the hypothesis that counterregulatory hormone responses are impaired in individuals with PBH, and that differences in the intestinal bacteria (microbiome) may contribute to this condition.

NCT ID: NCT04428723 Active, not recruiting - Hypoglycemia Clinical Trials

Mechanisms of Hypoglycemia in Patients Without Diabetes

Start date: August 11, 2020
Phase:
Study type: Observational [Patient Registry]

The goal of this study is to identify physiologic and molecular mechanisms that underlie hypoglycemia in the absence of diabetes (or medications that can cause hypoglycemia) and to investigate potential genetic and microbiome differences which contribute to hypoglycemia. We will test the hypothesis that hypoglycemia in the absence of diabetes is linked to genetic variation or the microbiome, and identify whether additional medical history or diagnoses are enriched in the population of patients with hypoglycemia.

NCT ID: NCT04387422 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

Recurrent Hypoglycemia in Type 1 Diabetes (Aim 2)

Start date: August 12, 2020
Phase: N/A
Study type: Interventional

This study will explore the cerebral mechanisms of impaired awareness of hypoglycemia (IAH) in type 1 diabetics following exposure to experimental recurrent hypoglycemia (HG). To induce IAH, patients with T1D identified to have normal awareness of hypoglycemia (NAH) will undergo three 2-hour long hypoglycemic clamps. Neurochemical profiles will be measured by high field MRS before and after induction of IAH. Subject glycemic variability and activity/sleep for 1 week before each study will be monitored as all factors have been shown to alter responses to HG.

NCT ID: NCT03914547 Active, not recruiting - Clinical trials for Type 1 Diabetes Mellitus

Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children

REDCHiP
Start date: October 15, 2019
Phase: N/A
Study type: Interventional

Investigators developed REDCHiP (Reducing Emotional Distress for Childhood Hypoglycemia in Parents), an innovative video-based telemedicine intervention. In the pilot work, investigators found preliminary efficacy for REDCHiP in reducing parental FH, parenting stress, and children's HbA1c. The objective of this clinical trial is to conduct a randomized clinical trial (RCT) comparing REDCHiP to a relevant attention control intervention (ATTN) in families of young children, thereby continuing to establish its efficacy. The proposed R01 aims are: 1) To evaluate whether parents who receive REDCHiP report reductions in FH and parenting stress at post-treatment compared to parents who receive the ATTN; 2) To evaluate whether children of parents who receive REDCHiP have a lower HbA1c and less glycemic variability at post-treatment compared to children of parents who receive ATTN; 3) To examine whether families who receive REDCHiP maintain reductions in FH, parenting stress, and child HbA1c at a 3-month followup compared to families who receive ATTN.

NCT ID: NCT03608163 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 1

Novel Approach for the Prevention of Hypoglycemia Associated Autonomic Failure (HAAF)

Start date: August 10, 2018
Phase: Phase 4
Study type: Interventional

The overall goal of this study is to develop a new and practical way to prevent the development of Hypoglycemia Associated Autonomic Failure (HAAF), which is unawareness of hypoglycemia (low blood sugar) in individuals with diabetes. Previous studies suggest that two medications, naloxone and diazoxide, may increase the body's ability to respond to episodes of low blood sugar and prevent the development of HAAF (or hypoglycemia unawareness). Only healthy subjects are being recruited for this study. The study has three distinct phases. In the first phase, healthy, non-diabetic individuals who are susceptible to developing HAAF are identified. Only these individuals will be studied in the second and third phases. The second phase of this study evaluates the effect of using a naloxone nasal spray versus a placebo nasal spray in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF. The third phase of this study evaluates the effect of using naloxone nasal spray and diazoxide in combination, compared to naloxone nasal spray plus a placebo (for diazoxide) or diazoxide plus a placebo (for naloxone) in improving the body's response to episodes of low blood sugar and in preventing the development of HAAF.