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Hyperinsulinism clinical trials

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NCT ID: NCT02835131 No longer available - Clinical trials for Congenital Hyperinsulinism

Compassionate Use of SOM230 for Hyperinsulinemic/Hypoglycemia

Start date: n/a
Phase:
Study type: Expanded Access

Congenital hyperinsulinism is a rare condition that can cause life-threatening hypoglycemia. Current treatment for congenital hyperinsulinism is often suboptimal, and such individuals may respond to a new somatostatin analog, pasireotide. This is a compassionate use study of the effects of pasireotide on individuals with suboptimally treated congenital hyperinsulinism.

NCT ID: NCT02653092 Completed - Obesity Clinical Trials

Reprometabolic Syndrome Mediates Subfertility in Obesity

Start date: June 2016
Phase: N/A
Study type: Interventional

Obesity plays an adverse role at every stage of conception and pregnancy and mounting evidence implicates relative hypogonadotropic hypogonadism, and reduced menstrual cycle hormone secretion as likely contributors to the subfertility phenotype and possible contributors to complications of pregnancy and the developmental origin of adult diseases such as diabetes and cardiovascular disease. This study will be the first comprehensive investigation to tie together the patterns of hyperinsulinemia, hyperlipidemia and inflammation, characteristic of obesity and obesity-caused relative hypogonadotropic hypogonadotropism and its potential adverse reproductive outcomes. The investigators findings will be used to inform a subsequent clinical intervention to optimize reproductive outcomes for obese women and their offspring.

NCT ID: NCT02642523 Withdrawn - Obesity Clinical Trials

Natriuretic Peptides and Metabolic Risk in Obesity

Start date: n/a
Phase: Early Phase 1
Study type: Interventional

The investigators are examining: 1. the relationships of insulin levels and natriuretic peptide hormone levels, and 2. the effects of administering an infusion of natriuretic peptide hormone on the breakdown of fat in healthy lean and otherwise healthy obese individuals.

NCT ID: NCT02604485 Completed - Clinical trials for Congenital Hyperinsulinism

A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism

Start date: October 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.

NCT ID: NCT02533219 No longer available - Clinical trials for Congenital Hyperinsulinism

Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia

[18F]-DOPA
Start date: n/a
Phase:
Study type: Expanded Access

The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI. The investigators will perform descriptive analysis, relying on visual analysis to diagnose and localize a focal lesion. Our findings will be compared to surgical histopathology to determine sensitivity and specificity or this technique. The investigators will also track patient surgical outcomes, specifically whether the patient is surgically "cured" or still requires medical management to control residual hypoglycemia.

NCT ID: NCT02524639 Withdrawn - Hyperinsulinism Clinical Trials

Sirolimus for the Treatment of Hyperinsulinism

Start date: August 12, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this pilot study is to generate data to assess feasibility of study design/procedures and for formal sample size estimation for a larger multicenter study of the efficacy and safety of sirolimus in infants with medically-unresponsive congenital hyperinsulinism (HI) due to inactivating mutations of adenosine triphosphate-sensitive potassium (KATP) channels.

NCT ID: NCT02248272 Completed - Hyperglycemia Clinical Trials

Effect of Meal Frequency on Glycemic Control of People at High Risk or Diagnosed With Diabetes

Start date: October 2011
Phase: N/A
Study type: Interventional

This study investigated any potential associations between two isocaloric diets with different meal frequency (3 meals versus 6 meals) and glycemic control in people at high diabetes risk (lean and overweight/obese women with PCOS, individuals with hyperinsulinemia, individuals with impaired glucose tolerance) and diagnosed with diabetes.

NCT ID: NCT02148250 Completed - Type 2 Diabetes Clinical Trials

PK/PD Study of U-500 Regular Insulin

Start date: July 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to learn more about how U500 regular insulin can be effectively be used to treat type 2 diabetes. Most insulin treated patients with type 2 diabetes take U100 insulin, but if they require large doses (such as >150 units a day) they may experience pain at this site of injection and the absorption of the insulin is unpredictable, thereby leading to poor glucose control. To overcome these problems, doctors sometimes switch to a more concentrated form of insulin called U500 insulin. U500 is five times as concentrated as U100 insulin and therefore delivers an equivalent dose of insulin in much lesser volume. However, how to best use U-500 insulin is not certain. The investigators are not really sure how long a given dose is effective in patients who require large doses (>150 units of U100 insulin), so are not sure of how often the drug should be administered. In this study, the investigators will determine how effective two different doses of U-500 regular insulin (100 U and 200 U) are in lowering blood sugar and how long these two doses last. This information will help doctors develop better treatment plans for patients with type 2 diabetes.

NCT ID: NCT02108730 Completed - Clinical trials for Non-focal Congenital Hyperinsulinism

Towards Individualized Surgery in Non-focal Congenital Hyperinsulinism

non-focal CHI
Start date: March 2011
Phase: N/A
Study type: Observational

Observational study in patients with non-focal congenital hyperinsulinism showing that restrictive surgery may improve the metabolic situation

NCT ID: NCT02021604 Recruiting - Insulinoma Clinical Trials

Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma

Start date: October 9, 2013
Phase: Phase 1
Study type: Interventional

Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI). This is a disease whereby the pancreas secretes too much insulin and causes low blood sugars. Twenty to forty percent of these babies will have brain damage. There are two forms of this disease. In one form only a small part of the pancreas makes too much insulin (focal HI) and in the other, the whole pancreas make too much insulin (diffuse HI). Another very similar disease is insulinoma which occurs after birth, but also causes hyperinsulinism. If a surgeon could know which part of the pancreas has the focal lesion he could remove it and cure the patient. The purpose of this study is to investigate whether a new investigational drug called Fluorodopa F 18, when used with a PET scan, can find the focal lesion and guide the surgeon to remove it, thus curing the patient and preventing further brain damage.