RightFit
Not yet recruitingPhase 1

Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe metformin is and how well people can handle taking it. It also looks at changes in blood markers linked to aging. It is for adults age 65 or older who have COPD, a long-term lung disease, but do not have diabetes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 65 or older.
  • Have COPD shown by a breathing test, with an FEV1/FVC ratio below 70%.
  • Have smoked at least 10 pack-years, such as 1 pack a day for 10 years.
  • In the past 12 months, had at least 1 COPD flare-up needing a hospital stay or 2 flare-ups treated without a hospital stay.

Who can't join

  • Have diabetes, already take metformin, or are allergic to metformin.
  • Have had lactic acidosis (too much lactic acid in the blood) not caused by a sudden, severe illness; or have had low vitamin B12 and will not start treatment.
  • Have liver damage, including cirrhosis (liver scarring) or abnormal liver blood tests; or have reduced kidney function, with an eGFR below 60.
  • Have problems with thinking or memory, including dementia.
  • Have heart failure with a pumping strength below 50%, or have alcohol use disorder (trouble controlling drinking).
  • Have a disability that prevents in-person visits.
  • Have an unstable health problem, such as unstable chest pain, worsening heart failure, or new nerve or brain symptoms; or had a COPD flare-up within 30 days before joining.
  • Take a carbonic anhydrase inhibitor, a type of medicine that includes topiramate, zonisamide, acetazolamide, and diclofenamide.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

NC