Antidiabetic Triple Therapy Effects on Surrogate Tests After Stroke

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Σύνδεση εγγραφή

Ο σύνδεσμος αποθηκεύεται στο πρόχειρο

ΚατάστασηΠρόσληψη

Χορηγοί

Chang Gung Memorial Hospital

Συνεργάτες

National Taiwan University Hospital

Chiayi Christian Hospital

ΚΛΙΝΙΚΉ ΔΟΚΙΜΉ: NCT04419337

BioSeek: nct04419337

Λέξεις-κλειδιά

Αφηρημένη

Background: Diabetes mellitus is a major risk factor of ischemic stroke. It is unsettled issue for which antidiabetic drugs is the best strategy for stroke patients with diabetes mellitus. Therefore it is important to figure out the most efficient way to prevent cardiovascular event in stroke patients. High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation and its level can independently predict risk of cardiovascular disease and can be used as a surrogate for future cardiovascular event.

Objective: To clarify whether triple therapy with combination with metformin, pioglitazone, and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) for 6 months can reduce hsCRP in stroke patients with diabetes mellitus.

Methods: This study will be conducted in 8 hospitals in Taiwan, enrolling 200 patients. Inclusion criteria were ischemic stroke within 6 months, having diabetes with Hb1c > 7%, eGFR > 45, no history of heart failure or amputation, and willing to sign informed consent. Patients will be randomly assigned to active treatment and conventional groups. In active arm, physicians will prescribe metformin, pioglitazone, and an SGLT2 inhibitor. In control arm, physicians will prescribe antidiabetic drug based on their personal experience. Treatment duration will be 6 months. The primary endpoint is hsCRP change from baseline in active vs control arm. The secondary endpoints are insulin resistance, BNP, albuminuria change from baseline in active vs control arm.

Expectation: IF combination therapy with metformin, pioglitazone, and an SGLT2 inhibitor is able to reduce inflammation and other biomarkers, such approach can be considered as priority therapy for ischemic stroke patients with diabetes.

Ημερομηνίες

Τελευταία επαλήθευση:	01/31/2020
Πρώτα υποβλήθηκε:	02/25/2020
Υποβλήθηκε εκτιμώμενη εγγραφή:	06/02/2020
Δημοσιεύτηκε για πρώτη φορά:	06/04/2020
Υποβλήθηκε τελευταία ενημέρωση:	06/02/2020
Δημοσιεύτηκε η τελευταία ενημέρωση:	06/04/2020
Ημερομηνία έναρξης της πραγματικής μελέτης:	09/30/2019
Εκτιμώμενη κύρια ημερομηνία ολοκλήρωσης:	07/30/2022
Εκτιμώμενη ημερομηνία ολοκλήρωσης μελέτης:	01/30/2023

Κατάσταση ή ασθένεια

Diabetes Mellitus

Stroke

Παρέμβαση / θεραπεία

Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor

Φάση

Φάση 2

Ομάδες βραχιόνων

Μπράτσο	Παρέμβαση / θεραπεία
Experimental: Active arm metformin+pioglitazone+an SGLT2 inhibitor
Active Comparator: Control arm metformin with or without combination with following oral antidiabetic drugs: DPP4 inhibitor, sulfonylurea, and acarbose.

Κριτήρια καταλληλότητας

Επιλέξιμες ηλικίες για μελέτη	20 Years Προς την 20 Years
Φύλα επιλέξιμα για μελέτη	All
Δέχεται υγιείς εθελοντές	Ναί
Κριτήρια	Inclusion Criteria: 1. Ischemic stroke within 6 months of randomization 2. Type 2 diabetes mellitus and Hba1C > 7.0% and under metformin currently or previously with or without other antidiabetic drugs 3. Estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2 4. Age ≥ 20 y at study entry 5. Ability and willingness to provide informed consent Exclusion Criteria: 1. History of congestive heart failure (NYHA class 1-4) 2. History of bladder cancer 3. History of repeated (> 2 episodes) urinary tract infection or genital tract infection 4. History of amputation 5. Irreversible medical conditions with predicted survival < 1 years 6. ALT > 100 mg/dl 7. Currently use insulin injection to control blood glucose 8. Currently use Glucagon-like peptide-1 receptor agonist to control blood glucose 9. Currently use pioglitazone or SGLT-2 inhibitor

Αποτέλεσμα

Πρωτεύοντα αποτελέσματα

1. hsCRP (high-sensitivity C-reactive protein) [6 months]

hsCRP change from baseline (i.e. 6-month hsCRP-baseline hsCRP) in active vs control groups

Δευτερεύοντα αποτελέσματα

1. HOMA-IR [6 months]

to evaluate insulin resistance in active vs control arms

2. BNP [6 months]

use BNP as an index of heart failure between active vs control arms

3. UACR [6 months]

to evaluate microalbuminuria in active vs control arms

4. Hba1C [6 months]

to evaluate glucose control in active vs control arms

Antidiabetic Triple Therapy Effects on Surrogate Tests After Stroke

Λέξεις-κλειδιά

φλεγμονή

εγκεφαλικό επεισόδιο

σακχαρώδης διαβήτης

insulin resistance

καρδιακή ανεπάρκεια

αντιδιαβητικός