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Набор скоро начнётся NCT07207980

Lifestyle Intervention for Type 2 Diabetes in Primary Care (CREDOenAP)

Без фазы С лечением Type 2 Diabetes Mellitus (T2DM)

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: CREDOenAP intervention.
Кому может быть актуально
Состояния в реестре: Type 2 Diabetes Mellitus (T2DM). Базовые параметры: 18 лет — 80 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
Испания
Следующий шаг
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Официальное название

Lifestyle Intervention Clinical Trial for the Remission of Type 2 Diabetes Mellitus in Primary Care (CREDOenAP)

Обзор

The purpose of this clinical trial is to determine whether an intensive lifestyle intervention can achieve remission of type 2 diabetes mellitus (T2DM) in adult patients treated in primary care. The main questions the study seeks to answer are: * What proportion of participants achieve diabetes remission after 6 months of intervention? * How many participants maintain remission 12 months after completing the program (18 months total)? Participants will: * Follow a personalized dietary plan with carbohydrate restriction. * Engage in moderate, accessible physical activity. * Implement strategies to improve circadian rhythm regularity. * Receive psychological counseling and support.

Вмешательства

  • Поведенческое CREDOenAP intervention
    Intervention program with intensive lifestyle counseling, added to standard pharmacological treatment subsequently adjusted according to clinical needs and outcomes. The intervention will last 6 months and consists of biweekly in-person and telephone visits. Patients will follow a personalized dietary plan with carbohydrate restriction, based on the recommendations of the American Diabetes Association; engage in moderate and accessible physical activity; implement circadian rhythm regularization

Первичные конечные точки

  • Presence of T2DM remission [Срок оценки: After 6 months of intervention and 12 months after the intervention]
Вторичные конечные точки (12)
  • Blood pressure [Срок оценки: After 6 months of intervention and 12 months after the intervention.]
  • Total cholesterol [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • HDL cholesterol [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • LDL cholesterol [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Apolipoprotein B100 (ApoB100) [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Triglycerides [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Presence and size of atherosclerotic plaques in carotid arteries [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Weight [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Body Mass Index (BMI) [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Abdominal circumference [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Insulin resistance [Срок оценки: After 6 months of intervention and 12 months after the intervention]
  • Pancreatic activity [Срок оценки: After 6 months of intervention and 12 months after the intervention]

Критерии участия

Критерии включения

  • Signed informed consent.
  • Men and women aged 18-80 years, inclusive.
  • Confirmed diagnosis of T2DM according to recognized diagnostic criteria
  • Most recent recorded hemoglobin A1c (HbA1c) > 6.5%.
  • Body Mass Index (BMI) greater than 27 kg/m².

Критерии исключения

  • Failure to meet the diagnostic criteria for T2DM in the screening laboratory tests.
  • Being dependent for basic activities of daily living (Barthel score ≤ 90 points).
  • Lack of willingness to cooperate with the follow-up of the lifestyle intervention plan.
  • Presence of serious or terminal comorbidities significantly worsening short- to medium-term prognosis (active cancer, terminal chronic diseases, myocardial infarction within the last 6 months, acute heart failure or NYHA stage ≥ III, etc.).
  • History of ketoacidosis.
  • Presence of criteria or potential autoimmune insulinopenia (abnormal C-peptide, anti-GAD+ antibodies, pattern of basal and/or glucose-stimulated hypoinsulinemia).
  • Cognitive impairment.
  • Weight loss exceeding 5 kg in the past 6 months.
  • Significant changes in physical activity and/or dietary patterns in the past 6 months.
  • History of eating disorders.
  • History of substance abuse.
  • History of severe psychiatric disorders.
  • Pregnancy or intention to become pregnant within the study period.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Parc Sanitari Pere Virgili — Barcelona

Идентификаторы

NCT: NCT07207980 · CREDOenAP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗