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Hyperinsulinism clinical trials

View clinical trials related to Hyperinsulinism.

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NCT ID: NCT06363929 Recruiting - Hyperinsulinism Clinical Trials

Continuous Glucose Monitoring in Neonatal Hyperinsulinism

Start date: June 1, 2023
Phase:
Study type: Observational

The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.

NCT ID: NCT06343974 Not yet recruiting - Clinical trials for Diabetes Mellitus, Type 1

Noninvasive Evaluation of Fetal Hyperinsulinemia With Ultrasound Radiomics

Start date: June 1, 2024
Phase:
Study type: Observational

The goal of this observational study is to compare fetal liver ultrasound radiomics between pregnancies complicated by type 1 diabetes and healthy controls. The main questions it aims to answer are: - Are fetal liver ultrasound radiomic features reproducible? - Does fetal liver ultrasound radiomics differ between pregnancies complicated by type 1 diabetes and healthy controls? Participants will undergo ultrasound examination to collect ultrasound data for the analyses.

NCT ID: NCT06208215 Recruiting - Clinical trials for Congenital Hyperinsulinism

RZ358 Treatment for Congenital Hyperinsulinism

sunRIZE
Start date: January 11, 2024
Phase: Phase 3
Study type: Interventional

The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to evaluate the longer-term safety and efficacy of RZ358 during a subsequent open-label extension (OLE) period.

NCT ID: NCT05989347 Not yet recruiting - Breast Cancer Clinical Trials

Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy

Start date: April 2024
Phase: Phase 1
Study type: Interventional

The primary objective of the study is to assess metabolic plasma markers of insulin resistance in patients with early-stage HER2-negative breast cancers receiving dapagliflozin concomitant with neoadjuvant therapy.

NCT ID: NCT05950282 Not yet recruiting - Obesity Clinical Trials

Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis

Start date: October 2023
Phase:
Study type: Observational [Patient Registry]

The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.

NCT ID: NCT05854251 Recruiting - PreDiabetes Clinical Trials

Hyperinsulinemia in Prediabetes Mediated by Interleukin-1β

Hyper-PreDIL
Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to test whether postprandial insulin secretion in subjects with prediabetes is mediated by Interleukin-1β and may be influenced by administration of the medicinal product anakinra (Kineret®). The main question it aims to answer is whether there is a difference in insulin secretion following a standardized mixed-meal test under anakinra compared to placebo.

NCT ID: NCT05774613 Recruiting - Hyperinsulinism Clinical Trials

Effect of Hibiscus Sabdariffa Beverage

Hibiscus
Start date: June 12, 2021
Phase: N/A
Study type: Interventional

There are numerous plant foods that are a source of bioactive compounds, which can induce an anti-inflammatory effect on various pathways of inflammatory processes in the body as it may be useful in decreasing markers of inflammation expressed by COVID-19 infectious disease and conditions such as obesity and its comorbidities. Given the above, Hibiscus sabdariffa hibiscus possesses advantages as a potential adjuvant in the management of COVID-19, as studies on the phytochemical properties of H. sabdariffa show that it has several health benefits, and could be used as a potent material for the therapeutic treatment of various diseases. Due to its high content of bioactive compounds, these can exert antioxidant, anti-inflammatory and anticarcinogenic effects, as well as help control blood glucose levels, prevent cardiovascular disease and obesity. In addition, it is a traditional component of the Mexican diet, of common consumption, easy incorporation in the diet, versatility in preparation and national production. Therefore, to evaluate the bioavailability of bioactive compounds present in a beverage developed from the TECNM/ITESO collaboration, as well as the glycemic and insulinemic response produced by its consumption; besides establishing the effect on some inflammation markers that may be activated as a consequence of the SARS-COV-2 virus infection. This will help to increase knowledge about potential treatment/prevention schemes, avoid the development of severe manifestations of the disease, as well as boost the production and market of a national product.

NCT ID: NCT05764200 Not yet recruiting - Insulin Sensitivity Clinical Trials

Acute Microbial Switch

Start date: July 1, 2023
Phase: N/A
Study type: Interventional

In this project the investigators will test if it is possible to measure changes in intestinal gas production after supplementation of a complex fiber mixture over a 36 hour period in both lean normoglycemic individuals and individuals with insulin resistance and/or prediabetes with overweight when compared with a placebo Changes in intestinal gas production will also be related to energy expenditure, substrate metabolism, microbial composition and related metabolites in feces, blood and urine.

NCT ID: NCT05753657 Recruiting - Clinical trials for Metastatic Breast Cancer

A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.

Start date: December 25, 2022
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.

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).