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Hyperinsulinism clinical trials

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NCT ID: NCT05733455 Completed - Insulin Resistance Clinical Trials

Effect of Alpelisib in Healthy Volunteers

Start date: May 9, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to test a single dose of the phosphoinositide-3-kinase (PI3K) inhibitor alpelisib versus placebo in healthy volunteers. The main questions it aims to answer are the impact of acute alpelisib-induced insulin resistance on parameters of glucose and lipid metabolism (how healthy people respond to temporary insulin resistance so that the investigators can see what happens to how the liver handles fat and sugar). Participants will: - Consume their total calculated daily caloric needs in nutritional supplements, divided in three meals, and otherwise fast for 24 hours - Take a dose of alpelisib 300 mg or placebo at bedtime - Wear a continuous glucose monitor for 72 hours - Participate in an oral glucose tolerance test (OGTT) Researchers will compare blood tests before and during OGTT in participants randomized (like the flip of a coin) to alpelisib versus placebo to see how the drug treatment affects plasma glucose, serum insulin, and serum lipid parameters (triglycerides, free fatty acids, and apolipoprotein B).

NCT ID: NCT05528874 Completed - Hyperglycemia Clinical Trials

NUTRACORE, Glycaemic Index and Appetite

NTRCR-vivo
Start date: April 22, 2022
Phase: N/A
Study type: Interventional

In recent decades, the world prevalence of obesity and type 2 diabetes (DMT2) has increased dramatically, resulting in a global epidemic. One of the aspects more connected to the etiology of these pathologies is undoubtedly the concept of the glycemic index (GI) and glycemic load (CG). It has been shown that, with the same CG, that is of carbohydrates contained in a food, a food with a higher GI tends to raise blood sugar more quickly (and consequently insulin), causing several negative effects on the body. We now have sufficient evidence to show that high GI diets are associated with increased incidence of DMT2, hyperlipoproteinemia, and cardiovascular disease. Although simple carbohydrates, namely sugars, have always been considered the major inducers of hyperglycemia and hyperinsulinemia, in reality also starches, or complex carbohydrates digestible by humans, may lead to an increase in blood sugar levels which is not as rapid but often equally harmful to health, since the GC is generally higher. The reason why a high GI diet is responsible for this increased risk of developing pathologies is not unambiguous. We can identify at least 4 probable mechanisms. 1. Sudden hyperglycemia tends to cause insulin to rise beyond what is necessary, leading subsequently to the risk of hypoglycemia and thus an excessive feeling of hunger. Increased energy intake and obesity. 2. Excess insulin secretion, aggravated by insulin resistance, represents an effort for the pancreas with the risk, over time, to arrive at a deficit of insulin-dependent diabetes type 2 insulin production 3. Hyperinsulinemia is also associated with reduced lipolysis and increased lipogenesis obesity and hyperlipoproteinemia 4. Fat accumulation, especially in the abdominal region, is associated with chronic inflammation and insulin resistance by type 2 diabetes tissues and metabolic syndrome In addition to these reasons, a high GI diet, typically called Western Diet, is also generally deficient in plant foods, rich in antioxidants and photo compounds with anti-inflammatory action, without which the process of chronic organic inflammation is accelerated, even in the absence of real obesity.

NCT ID: NCT05329337 Completed - Insulin Resistance Clinical Trials

Link Between the Peripheral Mononuclear Cells' Capacity to Induce Insulin Resistance and Hyperinsulinemia

IRACTIV
Start date: June 27, 2022
Phase: N/A
Study type: Interventional

This is a two-center proof-of-concept study, ancillary to the MetACTIV study, whose objective is to define immune activation profiles from the data of individuals followed by the Caisse Primaire d'Assurance Maladie du Gard (health insurance fund). The IRACTIV study will include a subset of volunteers from the MetACTIV study for whom a blood sample will be taken as part of the IRACTIV study.

NCT ID: NCT04992689 Completed - Clinical trials for Acquired ICU Bacteremia

Increasing Insulin Resistance as a Predictor of Impending Bacteremia

Start date: December 1, 2021
Phase:
Study type: Observational

Insulin resistance is defined as a decrease in the ability of insulin to lower blood glucose levels. Various pathological conditions can cause an increase in insulin resistance, such as sepsis, administration of certain medications, various stressful situations, surgery or significant injuries, etc. Sepsis can cause extreme stress, which causes significant changes in metabolism, disruption of blood glucose regulation and increased insulin resistance. In sepsis there is an extreme activation of inflammatory mediators and of counter-regulatory hormones, such as cortisol, glucagon and catecholamines, which increase hepatic gluconeogenesis on the one hand, and increase the peripheral resistance to insulin on the other hand. Disorder in the regulation of blood glucose level causes increased mortality and morbidity among intensive care unit patients with sepsis, as well as an increase in the duration of hospitalization and its financial expenses. There are a number of parameters used in the intensive care unit to diagnose the development of sepsis within the unit, such as an increase or decrease in body temperature, an increase in CRP level, white blood cell count, pro-calcitonin level, etc It is possible that an increase in insulin resistance can also be used as a predictor of sepsis. It should be noted that almost all patients hospitalized in the intensive care unit are treated with a continuous infusion of insulin to balance their blood glucose level, including patients who are not diagnosed with diabetes prior to their hospitalization in the unit. This is in light of the increase in insulin resistance for the reasons listed above among patients in critical condition, and also due to the need to maintain blood glucose values in the range of 140-180 mg/dl, since high blood glucose values among patients hospitalized in the intensive care unit are associated with increased morbidity and mortality. We would therefore like to investigate whether an increase in insulin resistance, as expressed in an increase in the patient's insulin intake, can predict the development of sepsis secondary to bacteremia in the intensive care unit.

NCT ID: NCT04909333 Completed - Clinical trials for Endogenous Hyperinsulinism

Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

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

This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).

NCT ID: NCT04538989 Completed - Clinical trials for Congenital Hyperinsulinism

An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism

Start date: February 24, 2020
Phase: Phase 2
Study type: Interventional

The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).

NCT ID: NCT04327245 Completed - Insulin Resistance Clinical Trials

To Compare the Effects of Non-nutritive Sweeteners Intake in Woman With Insulin Resistance

Start date: January 15, 2017
Phase: N/A
Study type: Interventional

ABSTRACT Introduction: There is no current data about the effects of non-nutritive sweeteners (NNS) about important factors, such as the energy intake, appetite and its relationship in people with insulin resistance when tasting sweet. It is highly relevant to compare the effects of NNS intake, such as, stevia (steviol glycosides) and D-tagatose, previous to a 75-gram oral glucose tolerance test (OGTT) on glycaemic and C-peptide responses in women with insulin resistance. Objective: To compare the effects of non-nutritive sweeteners intake: stevia (steviol glyco-sides) and sucralose previous to OGTT on appetite, glycemia and C-peptide plasmatic concentrations in women with insulin resistance. Methods: Thirty-three women with T2DM were studied in 3 different moments and they received 3 treatments: pre-load of water or D-tagatose or stevia and then offered to consume a 75-gram oral glucose tolerance test. Blood samples were obtained to measure the dependent variables, glycemic at times -10, 0, 30, 60, 90, 120 and 180 minutes and C-peptide at times -10, 30, 90, 120 and 180 minutes. The analogue visual scale questionnaires (VAS) was conducted every 30 minutes in order to obtain the results of the depend variables: appetite and wish of specific type of food in a subjective way; appetite, satiety, relax, wish to eat any food, craving for something sweet, craving for something salty, something tasty, something fatty. Through food provided ad libi-tum (objective appetite), were obtained the results of: energy, carbohydrates, proteins and lipid intakes. The statistical analysis applied included the Shapiro-Wilk's Normality test, repeated measures ANOVA to assess differences among treatments, Friedman's test followed by Wilcoxon test corrected by Bonferroni as needed. The degree of association between variables was conducted using the Pearson's or Spearman's correlation coefficient tests, as requested. A probability value p <0.05 was considered significant.

NCT ID: NCT04172441 Completed - Clinical trials for Congenital Hyperinsulinism

Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Start date: June 22, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.

NCT ID: NCT03856606 Completed - Clinical trials for Cardiovascular Diseases

The Effects of Interrupting Prolonged Sitting With Intermittent Exercise on Postprandial Lipemia

Start date: February 20, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effect of interrupting prolong sedentary behavior with interval exercise on postprandial metabolism following a high fat glucose tolerance test.

NCT ID: NCT03797222 Completed - Clinical trials for Hyperinsulinism-Hyperammonemia Syndrome

Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome

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

Investigators will assess the tolerability of oral Vitamin E supplementation in subjects with congenital hyperinsulinism (HI) and hyperammonemia (HA) syndrome.