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Идёт набор NCT05838287

Pioglitazone on Heart Failure in Type-2 Diabetes Mellitus Participants

Фаза IV С лечением Type 2 Diabetes Mellitus in Obese Heart Failure With Preserved Ejection Fraction

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
В протоколе указаны: Pioglitazone, Placebo.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes Mellitus in Obese, Heart Failure With Preserved Ejection Fraction. Базовые параметры: 30 лет — 70 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

Pioglitazone, Lipotoxicity, and Heart Failure With Preserved Ejection Fraction (HFpEF)

Обзор

Our goal of the study is to learn the effects of the diabetes medication named Pioglitazone, in type-2 diabetic obese participants with Heart failure. The main question it aims to answer are: 1. To demonstrate that impaired mitochondrial function leading to reduced ATP generation plays a key pathophysiologic role in the development of heart failure with preserved ejection fraction (HFpEF) in obese type 2 diabetic (T2D) individuals. 2. To demonstrate that pioglitazone, improves diastolic (as well as systolic) function by improving myocardial insulin sensitivity and by reducing both myocardial and epicardial fat content.

Подробное описание

Either Pioglitazone or Placebo Pioglitazone will be administered during this study in this Type 2 Diabetic population with Heart Failure to examine if there are any beneficial effects on diastolic and systolic function.

Myocardial blood flow (MBF) is measured using a PET scan, then participants will be randomized to pioglitazone or a placebo to examine the effects of the study drug on the effects on the systolic and diastolic function of the heart. In addition, myocardial insulin sensitivity change will be measured as well as myocardial fat content. The ratio of ATP: PCr will also be measured.

Вмешательства

  • Препарат Pioglitazone
    Participants will be taking Pioglitazone tablets 1/day for 24 weeks.
  • Препарат Placebo
    Placebo for Pioglitazone

Первичные конечные точки

  • Change in Systolic function [Срок оценки: Baseline and 6-months post treatment (approximately 24 weeks)]
  • Change in Diastolic function [Срок оценки: Baseline and 6-months post treatment (approximately 24 weeks)]
Вторичные конечные точки (3)
  • Myocardial insulin sensitivity [Срок оценки: Baseline and 6-months post treatment (approximately 24 weeks)]
  • Myocardial fat content [Срок оценки: Baseline and 6-months post treatment (approximately 24 weeks)]
  • PCr:ATP ratio [Срок оценки: Baseline and 6-months post treatment (approximately 24 weeks)]

Критерии участия

Критерии включения

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 30-70 years
  • Body Mass Index (BMI) of 27.5-40kg/m²
  • HbA1c of 6.5 to 10%
  • Blood pressure of less than or equal to 145/65mmHg
  • eGFR greater than 45 ml/min/1.73m²
  • Subject must have HFpEF (EF > 50% by ECHO screening)
  • NYHA class II-III heart failure
  • Only T2D patients treated with diet/exercise, metformin, sulfonylurea, metformin/SU, DPP4i or insulin will be studied.
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional \[4 weeks\] after the end of study participation.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Критерии исключения

  • Subjects with history of osteoporosis or proliferative diabetic retinopathy
  • Subjects with Heart failure due to restrictive or infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, severe valvular heart disease, etc. will be excluded
  • Patients with symptomatic coronary artery disease.
  • Subjects with significant change in diuretic management during the month prior to screening (defined by doubling of diuretic dose, or addition of another HF medication).
  • Subjects treated with a GLP-1 RA or thiazolidinedione.
  • Subjects treated with a SGLT2i
  • Pregnancy or lactation
  • Known allergic reactions to components of the study interventions.
  • Any metal plates, parts, screws, shrapnel, pins in body, or cardiac (heart) pacemaker

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Texas Diabetes Institute/UH — San Antonio

Идентификаторы

NCT: NCT05838287 · HSC20220916H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗