Phase 2
N=40
Metformin Effect on Brain Function in Insulin Resistant Elderly People
Insulin Resistance · Obesity · Obesity, Abdominal
Bottom Line
View on ClinicalTrials.gov: NCT03733132 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jun 2024
Primary outcome: Primary: Change From Baseline in Brain PCr/ATP Ratio as Measured by Phosphorus Magnetic Spectroscopy (31P-MRS) After 10 Months of Metformin Administration — -0.045; -0.016 PCr/ATP ratio — p=0.854
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Metformin Hydrochloride (Drug); Placebo Oral Tablet (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Brain PCr/ATP Ratio as Measured by Phosphorus Magnetic Spectroscopy (31P-MRS) After 10 Months of Metformin Administration |
-0.045; -0.016 | 0.854 |
| PRIMARY Change From Baseline in Cognitive Function as Measured by NIH Toolbox After 10 Months of Metformin Administration |
1.450; 2.900 | 0.389 |
| SECONDARY Change From Baseline in Brain Structure as Measured by MRI After 10 Months of Metformin Administration |
-2255.098; 1588.247 | 0.609 |
| SECONDARY Change From Baseline in Muscle Mitochondrial Respiration as Measured by High-resolution Respirometry Following 10 Months of Metformin Administration |
-0.106; -0.926 | 0.371 |
| SECONDARY Change From Baseline in Muscle Mitochondrial ATP Production as Measured by Fluorometry Following 10 Months of Metformin Administration |
5.760; 8.899 | 0.686 |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03733132). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.