Effect of Metformin on Frailty in 12 Subjects
Condition: Aging; Inflammation; Frailty
MeSH terms: Inflammation; Frailty
Intervention: Metformin; Placebo
Intervention description: Oral metformin (up to 2gm) will be given in divided doses; Oral Placebo will be given in divided doses
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arms Assigned interventions Placebo Comparator: Metformin Chronic metformin administration through augmentation of cellular regeneration and reduction of senescence will improve frailty and physical functioning as studied by the short physical performance battery (SPPB) test. Drug: Metformin versus placebo This will be a pilot, feasibility study. Twelve subjects ≥60 years with stable CAD and prediabetes, who score <9 on SPPB test will be randomized to receive up to 2gm of oral metformin or placebo for 12 months.
Placebo comparator: Placebo Placebo will be compared to chronic metformin administration Drug: Metformin versus placebo This will be a pilot, feasibility study. Twelve subjects ≥60 years with stable CAD and prediabetes, who score <9 on SPPB test will be randomized to receive up to 2gm of oral metformin or placebo for 12 months.
Masking: Double (Participant, Investigator)
Enrollment: 7.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

Summary:

      This study will test whether chronic metformin administration will improve longevity of the
      cell, improves its machinery by reducing aging-related biochemical parameters and thereby
      improving physical performance, as measured by short physical performance battery test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥ 60 years

          -  Stable CAD

          -  Prediabetes (one of the following criteria should be met)

               -  Fasting plasma glucose: 100-126 mg/dL

               -  HbA1C: 5.7-6.4

          -  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

          -  Acute coronary syndrome <3months or participating in cardiac rehabilitation

          -  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