CMR in Type 2 Diabetes Mellitus Patients

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Вход / Регистрация

Линкът е запазен в клипборда

СъстояниеЗавършен

Спонсори

Slagelse Hospital

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT02684331

BioSeek: NCT02684331

Ключови думи

Резюме

The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.

This study project sets out to answer the following hypotheses:

1. Patients with T2DM have an increased risk of developing diastolic dysfunction. Using CMR, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. The investigators hypothesize that classic T2DM markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM duration, etc. are associated with pathological findings by CMR.

2. Patients with T2DM have impaired left ventricle myocardial perfusion as determined by gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast CMR.

Дати

Последна проверка:	08/31/2019
Първо изпратено:	02/07/2016
Очаквано записване подадено:	02/10/2016
Първо публикувано:	02/17/2016
Изпратена последна актуализация:	09/17/2019
Последна актуализация публикувана:	09/18/2019
Действителна начална дата на проучването:	12/31/2015
Приблизителна дата на първично завършване:	06/30/2019
Очаквана дата на завършване на проучването:	06/30/2019

Състояние или заболяване

Diabetes Mellitus, Type 2

Heart Disease

Интервенция / лечение

Other: T2DM

Фаза

Групи за ръце

Arm	Интервенция / лечение
T2DM	Other: T2DM An extensive explorative CMR protocol, including time/volume curves of LV and LA, rest and stress perfusion (with Adenosin) and time/volume curve of LA after chronotropic stress with Glycopyrrolate, further flow measurements and T1 mapping.

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Метод за вземане на проби	Non-Probability Sample
Приема здрави доброволци	Да
Критерии	Inclusion Criteria: - Male or female patient fully capable of informed consent - Informed consent - T2DM - Age 18-80 (both years included) Exclusion Criteria: - Contraindications to CMR (pacemakers/ICD-units, cochlear implants) - Lack of consent - Atrial fibrillation - eGFR < 30 ml/min/1,73m2 (only exclusion criteria for gadolinium contrast study) - Women of childbearing potential who are not on acceptable contraception - Severe claustrophobia (only contraindication for CMR but can undergo echocardiography and other examinations) - Contraindications to adenosine: history of significant bronchial asthma, 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, incompensated heart failure - Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis

Резултат

Първични изходни мерки

1. On CMR; left ventricle peak filling rate (ml/s) [Cross-sectional so at baseline]

Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress

2. On CMR, LV myocardial perfusion [Cross-sectional so at baseline]

Including measurements at rest and with Adenosin stress

3. On CMR; passive atrial emptying fraction (%) as a measure for cardiac diastolic function [Cross-sectional so at baseline]

Measure for cardiac diastolic function; including measurements at rest and after glycopyrrolate chronotropic stress

Вторични изходни мерки

1. Echocardiography [Cross-sectional so at baseline]

Systolic function

2. Blod samples [Cross-sectional so at baseline]

NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3

3. Echocardiography [Cross-sectional so at baseline]

Diastolic function

CMR in Type 2 Diabetes Mellitus Patients

Ключови думи

захарен диабет тип 2

захарен диабет

хиперлипидемии

дислипидемии

албумин