Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Determine feasibility of metformin administration in older persons with COPD without diabetes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
Metformin
Metformin in COPD patients without diabetes
干预措施: Metformin (Drug)
结局指标
主要结局
Determine feasibility of metformin administration in older persons with COPD without diabetes
时间窗: 6 months
Enroll and retain ≥ 30 (66%) participants through 6 months study period
Determine acceptability of metformin administration in older persons with COPD without diabetes
时间窗: 6 months
≥70% completion of daily symptom diaries \& weekly adherence logs
Determine safety of metformin administration in older persons with COPD without diabetes
时间窗: 6 months
≥90% of the blood glucose levels, renal and hepatic function will be within normal limits\*; All lactate levels will be normal
Determine tolerability of metformin administration in older persons with COPD without diabetes
时间窗: 6 months
Adverse events and Serious adverse events
次要结局
未报告次要终点