A Study to Evaluate the Effect of Metformin on Frailty in 12 Subjects (6 Metformin/6 Placebo in a Randomized Fashion)

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 17-003088
    NCT ID: NCT03451006
    Sponsor Protocol Number: 17-003088

About this study

The purpose of this study is to test whether chronic metformin administration will improve longevity of the cell, improve its machinery by reducing aging-related biochemical parameters, and improve physical performance as measured by short physical performance battery test.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Age ≥ 60 years
  • CAD
  • Frailty (Short Physical Performance Battery: Score <9)
  • Able to return for follow-up
  • Written informed consent

Exclusion Criteria:

  • Pre-existing or new-onset diabetes
  • Any active malignancy, hematological disorder, post organ transplant, immunocompromised
  • Cancer requiring treatment in the past 3 years (other than non-melanoma skin cancer)
  • Dementia [mini mental state examination (MMSE <20)]
  • Disability (need for assistance in >2 of any six activities on Katz activities of daily living (ADL)46
  • Prior stroke with disability
  • Severe Parkinson's
  • Hepatic insufficiency and/or chronic liver disease (cirrhosis)
  • Chronic kidney disease (GFR < 45 mL/min)
  • Taking metformin for any indication
  • Acute alcohol intoxication
  • Known hypersensitivity to metformin hydrochloride
  • Acute/chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mandeep Singh, M.D.

Open for enrollment

Contact information:

Kimberly Osmundson CCRP

(507)255-6770

Osmundson.Kimberly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20399420

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