Antecedent Metabolic Health and Metformin Aging Study
Status:
Recruiting
Trial end date:
2024-04-30
Target enrollment:
Participant gender:
Summary
Aging is the number one risk factor for the majority of chronic diseases. There are no
pharmaceutical treatments to slow aging and prolong healthspan. The anti-diabetic drug
metformin is considered a likely pharmaceutical candidate to slow aging. In this study, the
investigators hypothesize that metformin treatment in subjects free of type 2 diabetes will
improve insulin sensitivity and glucoregulation in insulin resistant individuals, but will
decrease insulin sensitivity and glucoregulation in insulin sensitive subjects. Further, the
investigators hypothesize that long-term metformin treatment will remodel mitochondria in a
way that decreases mitochondrial function in subjects that are insulin sensitive, but
improves mitochondrial function in subjects that are insulin resistant. The investigators
will use a dual-site, 12- week drug intervention trial performed in a double-blind,
placebo-controlled manner on 148 subjects recruited from two separate sites (Oklahoma Medical
Research Foundation (OMRF) and University of Wisconsin-Madison (UWM)). After consent and
initial subject screening for chronic disease, subjects will be stratified to insulin
sensitive (IS) or insulin resistant (IR) groups. Over a 12- week intervention, half of each
group will take metformin and half will take a placebo. Pre- and post--intervention, subjects
will complete a series of procedures to assess insulin sensitivity, glucose regulation, and
biomarkers of aging. The same subjects will provide a skeletal muscle biopsy pre-- and
post-intervention to assess the change in mitochondrial function and mitochondrial remodeling
with and without metformin treatment. By completion of this project, the investigators expect
to provide evidence that helps further delineate who may benefit from metformin treatment to
slow aging.
Phase:
Phase 3
Details
Lead Sponsor:
Oklahoma Medical Research Foundation
Collaborators:
National Institute on Aging (NIA) University of Illinois at Urbana-Champaign University of Oklahoma University of Wisconsin, Madison