Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes After New Onset of STEMI
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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: ST-segment Elevation Myocardial Infarction (STEMI), Diabetes Mellitus, Insulin Resistance, Non-Alcoholic Fatty Liver Disease. 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
- Германия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Metabolic Phenotyping and Follow-Up of Patients With and Without Diabetes Mellitus After New Onset of ST-Segment Elevation Myocardial Infarction (STEMI) (DISTEMI Study)
Обзор
The aim of the prospective observational DISTEMI-Study in people with and without Diabetes mellitus (DI) after new onset of ST-Segment Elevation Myocardial Infarction (STEMI) aged 18-80 years at inclusion into the study is to characterize in detail the clinical, metabolical, immunological and vascular phenotype, investigate the interplay between myocardial remodelling and the metabolic phenotype, monitor the progression of the disease and compare the phenotype of STEMI people with diabetes mellitus to people with prediabetes and glucose tolerant people.
Подробное описание
In detail, the following questions will be answered:
1. Do distinct metabolic phenotypes (with respect to insulin secretion, insulin sensitivity, circulating free fatty acids and ectopic lipid storage, especially in the liver) determine myocardial infarct size and decline of contractile function of the remote myocardium? 2. Which factors modify the progression of the disease (insulin resistance, ectopic lipid storage, subclinical inflammation, abnormal energy metabolism)? People are thoroughly examined at baseline and one year after STEMI. 3. Can we identify risk profiles and their relevance for development of diabetes-associated complications as well as long-term progression of diabetes? 4. Can we improve risk assessment algorithms for targeted therapy in line with Precision Medicine?
Первичные конечные точки
- Change of cardiac function [Срок оценки: One year]
Вторичные конечные точки (9)
- Change of insulin sensitivity (M-Value) [Срок оценки: One year]
- Change of insulin secretion [Срок оценки: One year]
- Change of ectopic fat distribution [Срок оценки: One year]
- Change of liver stiffness [Срок оценки: One year]
- Change of energy metabolism [Срок оценки: One year]
- Change of mitochondrial respiratory function [Срок оценки: One year]
- Change of Fatty liver index [Срок оценки: One year]
- Change of Homeostasis Model Assessment 2 Estimate [Срок оценки: One year]
- Incidence of further cardiovascular diseases (CVD) and STEMI-related complications, new onset of prediabetes and diabetes mellitus and associated comorbidities [Срок оценки: One year]
Критерии участия
Критерии включения
- Condition after new onset of ST-segment elevation myocardial infarction (STEMI)
- Age 18-80 years
- HbA1c <9.0%
- People with diagnosis of diabetes mellitus according to ADA and DDG criteria (i.e. HbA1c ≥6.5% and/or pathological oral glucose tolerance test)
- Healthy people with normal glucose tolerance status according to ADA and DDG criteria (i.e. HbA1c <5.7% and normal OGTT)
- People with impaired glucose metabolism ("prediabetes") according to ADA and DDG criteria (i.e. impaired fasting glucose and/or impaired glucose tolerance and/or HbA1c 5.7-6.4%)
- Consent-able, hemodynamically stable people, without sedation (e.g. opiates) or other interfering medication (e.g. catecholamines)
Критерии исключения
- Diabetes mellitus category 3 A-H (ADA criteria), gestational diabetes
- Current pregnancy
- Infectious diseases, acute infections / fever
- Immunosuppressive therapy
- Severe chronic renal, liver or heart disease (e.g. serum creatinin ≥1.6 mg/dl, peripheral artery occlusive disease stage IV)
- Malignant diseases
- Severe chronic psychiatric illness or addiction
- Participation in an intervention trial
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
Германия · 1 центр
- German Diabetes Center — Düsseldorf
Публикации
- Moser C, Prystupa K, Schon M, Yurchenko I, Bodis KB, Huttasch M, Michelotti F, Kupriyanova Y, Schrauwen-Hinderling V, Granata C, Bonhof GJ, Strom A, Herder C, Dorr D, Trenkamp S, Heilmann G, Bobrov P, Strassburger K, Szendroedi J, Cramer M, Polzin A, Jung C, Kelm M, Burkart V, Wagner R, Roden M, Zaharia OP. Cohort profile: The DIabetes and ST-segment Elevation Myocardial Infarction (DISTEMI) Study PMID 41821026
- Heilmann G, Trenkamp S, Moser C, Bombrich M, Schon M, Yurchenko I, Strassburger K, Rodriguez MM, Zaharia OP, Burkart V, Wagner R, Roden M. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes. Clin Chem Lab Med. 2023 Oct 24;62(4):762-769. doi: 10.1515/cclm-2023-0770. Print 2024 Mar 25. PMID 37870928
Идентификаторы
NCT: NCT05046483 · DISTEMI-Study-01