Antidiabetic Triple Therapy Effects on Surrogate Tests After Stroke

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状态招聘中

赞助商

Chang Gung Memorial Hospital

合作者

National Taiwan University Hospital

Chiayi Christian Hospital

临床试验: NCT04419337

BioSeek: nct04419337

关键词

抽象

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.

日期

最后验证:	01/31/2020
首次提交:	02/25/2020
提交的预估入学人数:	06/02/2020
首次发布:	06/04/2020
上次提交的更新:	06/02/2020
最近更新发布:	06/04/2020
实际学习开始日期:	09/30/2019
预计主要完成日期:	07/30/2022
预计完成日期:	01/30/2023

状况或疾病

Diabetes Mellitus

Stroke

干预/治疗

Drug: Metformin plus Pioglitazone plus an SGLT2 inhibitor

相

相 2

手臂组

臂	干预/治疗
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.

资格标准

有资格学习的年龄	20 Years 至 20 Years
有资格学习的性别	All
接受健康志愿者	是
标准	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

结果

主要结果指标

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

次要成果指标

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

关键词

inflammation

stroke

diabetes mellitus

insulin resistance

heart failure

抗糖尿病

抽象

日期

状况或疾病

干预/治疗

相

手臂组

资格标准

结果

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