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Набор по приглашению NCT07102043

Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)

— Наблюдательное Cystic Fibrosis Related Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Cystic Fibrosis Related Diabetes. Базовые параметры: 21 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Glucose Metabolism in CFRD: Exploring the Role of CFTR Modulators in Metabolic Dysfunction

Обзор

The study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI). CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI) will be the control group.

Подробное описание

This is a mechanistic observational study. It is NOT a clinical trial. A physiological challenge of a single mixed meal tolerance test (MMTT) is administered, which will enable a comprehensive assessment of multiple parameters of glucose turnover, insulin secretion, insulin sensitivity and lipolysis in individuals with CFRD. The MMTT is the gold standard for measuring both insulin action and secretion simultaneously with glucose kinetics. The pilot study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI).

We plan to gather critical preliminary data on the following aspects of CFRD:

1. Abnormalities in specific components (basal vs. static vs. dynamic) of beta-cell function in CFRDF508del+ETI and in CFRD-ETI individuals. 2. Effects of ETI on components of beta cell function. 3. Effects of CFTR mutation and of CFTR modulators (CFRDF508del+ETI) on insulin sensitivity and post prandial glucose turnover in CFRD.

Первичные конечные точки

  • Disposition Index in CFRD [Срок оценки: Day 1 During the Mixed meal test]
Вторичные конечные точки (1)
  • Post prandial glucose turnover [Срок оценки: Day 1 During the mixed meal test]

Критерии участия

Критерии включения

  • Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)
  • Age 21-75 years at time of consent
  • BMI 19-50 kg/m2 (In Asians BMI is \~ 2 points lower for comparison so it is 17-48 kg/m2)
  • Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men
  • HbA1c ≤ 11% lifestyle treatment or mono/combination therapy with oral hypoglycemic agents (e.g. metformin or sulphonylurea or SGLT2i) and preferably on insulin pump therapy (i.e., SAP, HCL) with or without CGM will be recruited. However, use of MDI (Multiple Daily Injections) of insulin, i.e., on basal-bolus insulin therapy will also be included. Most of our patients are on insulin therapy with very few on oral antidiabetes medications but we would like to offer them the choice of participation.
  • Subjects on FDA approved/recommended full doses of ETI will be offered participation. If dose adjustments of ETI are made after enrollment a discussion will be done with the primary care provider and HCSTOC as required.
  • Willing to be at a stable weight for duration of the study.
  • An understanding of and willingness to follow the protocol and sign the informed consent

Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation:

Критерии исключения

  • Debilitating chronic disease
  • Anemia <10.0 gm/dL in females and <11.0 gm/dL in males
  • Symptoms of undiagnosed illness on history/exam
  • Abuse of alcohol or recreational drugs
  • Pregnancy
  • Active hepatic disease (we will include only if less than 3X ULN for liver enzymes and no fibrosis on ultrasound). Transient elevations of liver enzymes will not exclude participation but will be discussed with the primary care provider and HCSTOC as required.
  • Current use of the following drugs and supplements:

i. Corticosteroids ii. Benzodiazepines iii. Opiates iv. Barbiturates v. Anticoagulant therapy vi. Any other medication that the investigator believes is a contraindication to the subject's participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

США · 1 центр
  • University of Alabama at Birmingham — Birmingham

Идентификаторы

NCT: NCT07102043 · IRB300014949 · P30DK072482

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗