Obesity Clinical Trial
Official title:
Metformin Effect on Brain Function in Insulin Resistant Elderly People
Verified date | March 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | April 5, 2023 |
Est. primary completion date | April 5, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in brain PCr/ATP ratio as measured by phosphorus Magnetic Spectroscopy (31P-MRS) after 10 months of metformin administration | Multivoxel spectroscopic imaging of the brain will be performed using our dual-tuned single-channel-proton eight-channel-phosphorus head coil. A single 2.5 cm thick slice will be prescribed to encompass the temporal and occipital lobes, and weighted MRSI will be performed using a 16x16 matrix to acquire nominal 2.5 cm3 voxels. | Baseline, 10 months | |
Primary | Change from baseline in brain functional connectivity as measured by fMRI after 10 months of metformin administration | To measure global brain functional network information, an axial 2D echo-planar imaging sequence with 3mm isotropic voxels (FA=90, TE=30, TR=2000, # slices=50) will be used to acquire resting state functional MRI data throughout the brain. | Baseline, 10 months | |
Primary | Change from baseline in cognitive function as measured by NIH Toolbox after 10 months of metformin administration | The NIH Toolbox will be utilized to measure cognitive outcomes. The NIH Toolbox-Cognition Battery is composed of 7 tests (~30 minutes) including the Dimensional Change Card Sort (DCCS) Test (executive function), the Flanker Inhibitory Control Test (executive function), the Picture Sequence Memory Test (episodic memory), the Picture Vocabulary Test (vocabulary), the Oral Reading Recognition Test (reading), the List Sorting Working Memory Test (working memory), and the Pattern Comparison Processing Speed Test (processing speed. Our primary outcome measure will be the Total Cognition Composite score. | Baseline, 10 months | |
Secondary | Change from baseline in brain structure as measured by MRI after 10 months of metformin administration | AA sagittal 3D MPRAGE sequence with 0.7mm isotropic voxels (TR=2400, TE=2.57, TI=1100, FA=8) will be used to acquire high-resolution structural data for volumetric analysis of brain region changes related to metformin. To measure white matter information: An axial 2D symmetric multi-slice (SMS) diffusion tensor imaging (DTI) sequence with 60 diffusion directions, 5 B0 acquisitions and 2mm isotropic voxels (TR=3000, TE=73, FA=90, ETL 43, both A-P and P-A phase encoding for B0 images) will be used to acquire white matter integrity data related to metformin. | Baseline, 10 months | |
Secondary | Change from baseline in muscle mitochondrial respiration as measured by high-resolution respirometry following 10 months of metformin administration | High-resolution respirometry will be used to analyze oxygen consumption in isolated mitochondria from skeletal muscle biopsy samples while simultaneously quantifying reactive oxygen species (ROS) production using amplex red. ATP production rates will be concurrently measured using high sensitivity fluorometry. | Baseline, 10 months | |
Secondary | Change from baseline in muscle mitochondrial ATP production as measured by fluorometry following 10 months of metformin administration | Concurrent to mitochondrial respiration, muscle mitochondrial ATP production will be measured using high-sensitivity fluorometry. | Baseline, 10 months |
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