Metformin Effect on Brain Function in Insulin Resistant Elderly People

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Alzheimer's disease (AD) and other forms of dementia are rapidly increasing with the aging of the population, and show a clear preponderance among people with insulin resistance. Metformin, an insulin sensitizer, is being examined in clinical trials as an anti-aging drug. However, very little objective data is available regarding metformin's effect on the brain, a major organ affected by aging.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Institute on Aging (NIA)
• Treatments: Insulin; Metformin

Criteria

Inclusion Criteria:

• Age >/= 65 years

• Abdominal girth > 102 cm in men and > 88 cm in women-

• Fasting glucose >/= 100-140 mg/dL

• Non-smoker

• English language proficiency

Exclusion Criteria:

• Coronary artery disease or heart failure

• A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

Inpatient psychiatric treatment in the past 6 months

• Presence of a known adrenal disorder

• Abnormal liver function test results (Transaminase >2 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function

• Abnormal renal function tests results (calculated GFR <60 mL/min/1.73m2); testing required for subjects with diabetes duration of greater than 5 years post onset of puberty

• Active gastroparesis

• If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of stability on the medication for the past 2 months prior to enrollment in the study

• Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L): testing required within here months prior to admission for subjects with a goiter, positive antibodies, or who are on thyroid hormone replacement, and within one year otherwise

• Abuse of alcohol or recreational drugs

• Infectious process not anticipated to resolve prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis)

• Uncontrolled arterial hypertension (Resting diastolic blood pressure >90 mmHg and/or systolic blood pressure >160 mmHg) at the time of screening

• Oral steroids

• A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol

• Any metal in the body that could interfere with magnetic resonance imaging (MRI) including pacemaker or implanted defibrillator, neurostimulators, ear implants, metal fragments within the body, metal joints, rods, pins, plates or screws

• Medications that may impact study end points such as mitochondrial biology eg. beta blockers

• Anti-hyperglycemic drugs including metformin

• Any other medication that the investigator believes is a contraindication to the subject's participation