研究肺康复中衰老细胞清除特性及二甲双胍在COPD急性加重中的作用 (INSPIRE-COPD-E)
The purpose of this study is to investigate the safety and tolerability of Metformin and how it changes blood markers associated with aging in persons who have chronic obstructive pulmonary disease (COPD) who do not have diabetes.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Christopher Mosher, MD
- 电话号码:(919) 684-8111
- 邮箱:christopher.mosher@duke.edu
研究联系人备份
- 姓名:Jessica Shier
- 电话号码:(919) 684-9139
- 邮箱:jessica.shier@duke.edu
学习地点
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- Duke Asthma, Allergy, and Airway Center
-
接触:
- Jessica Shier
- 电话号码:(919) 684-9139
- 邮箱:jessica.shier@duke.edu
-
首席研究员:
- Christopher Mosher, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age 65 and older
- History of COPD defined by spirometry demonstrating FEV1/FVC < 70%
- 10 or more tobacco pack year history
- History of frequent exacerbations defined as: 1 severe (i.e., COPD hospitalization) or 2 moderate (i.e., outpatient treated exacerbations) in the previous 12 months
Exclusion Criteria:
- Diabetes or actively being treated with metformin
- Metformin allergy
- History of lactic acidosis not explained by acute, severe illness
- History of low vitamin B12 levels and unwilling to begin standard of care treatment for low vitamin B12 levels
- Hepatic impairment defined as history of cirrhosis or abnormal liver function tests (e.g., alanine transaminase (ALT): 7-55 units per liter (U/L), aspartate transaminase (AST): 8-48 U/L, alkaline phosphatase (ALP): 40-129 U/L, or bilirubin: 0.1-1.2 milligrams per deciliter (mg/dL))
- Renal impairment defined as eGFR < 60 mL/min/1.73m2
- Cognitive impairment
- Dementia
- Heart failure with reduced ejection fraction < 50%
- Alcohol use disorder
- Disability preventing in-person visits
- Persons with an unstable medical condition (including but not limited to unstable angina, acute heart failure exacerbation, acute neurological symptoms) or COPD exacerbation within 30 days prior to enrollment will be excluded
- Active treatment with Carbonic Anhydrase Inhibitors including but not limited to topiramate, zonisamide, acetazolamide, diclofenamide
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Metformin
Metformin in COPD patients without diabetes |
All enrolled participants will receive open-label Metformin for a treatment period of 6 months. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Determine feasibility of metformin administration in older persons with COPD without diabetes
大体时间:6 months
|
Enroll and retain ≥ 30 (66%) participants through 6 months study period |
6 months
|
|
Determine acceptability of metformin administration in older persons with COPD without diabetes
大体时间:6 months
|
≥70% completion of daily symptom diaries & weekly adherence logs |
6 months
|
|
Determine safety of metformin administration in older persons with COPD without diabetes
大体时间:6 months
|
≥90% of the blood glucose levels, renal and hepatic function will be within normal limits*; All lactate levels will be normal |
6 months
|
|
Determine tolerability of metformin administration in older persons with COPD without diabetes
大体时间:6 months
|
Adverse events and Serious adverse events |
6 months
|
合作者和调查者
调查人员
- 首席研究员:Christopher Mosher, MD、Duke University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Pro00116416
- 1K76AG095138-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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