Phase 4
Completed N=16
Metformin in Longevity Study (MILES).
Source: ClinicalTrials.gov NCT02432287 ↗Enrolled (actual)
16
Serious AEs
3.3%
Results posted
May 2018
Primary outcomePrimary: Increase in Number of Expressed Genes in Muscle and Adipose Tissue Using RNA Sequencing (RNA-Seq) — 245; 402; 15; 132 genes
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Metformin, an FDA approved first-line drug for the treatment of type 2 diabetes, has known beneficial effects on glucose metabolism. Evidence from animal models and in vitro studies suggest that in addition to its effects on glucose metabolism, metformin may influence metabolic and cellular processes associated with the development of age-related conditions, such as inflammation, oxidative damage, diminished autophagy, cell senescence and apoptosis. As such, metformin is of particular interest in clinical translational research in aging since it may influence fundamental aging factors that underlie multiple age-related conditions. The investigators therefore propose a pilot study to examine the effect of metformin treatment on the biology of aging in humans. Namely, whether treatment with metformin will restore the gene expression profile of older adults with impaired glucose tolerance (IGT) to that of young healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Increase in Number of Expressed Genes in Muscle and Adipose Tissue Using RNA Sequencing (RNA-Seq) |
245; 402; 15; 132 | — |
| SECONDARY Mixed Meal Tolerance. Assessment of Insulin Sensitivity and Insulin Secretion (Using a Modification of the Matsuda Index) |
5.6; 4.1 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women;
- age >60 years with IGT based on 75g OGTT (fasting plasma glucose 1.4 mg/dl (female) or > 1.5 mg/dl (male), active liver disease, history of metabolic acidosis, poorly controlled hypertension, epilepsy, recent (within 3 months) CVD event (MI, PTCA, CABG, stroke); history of bariatric or other gastric surgery, cigarette smoking, binge alcohol use (>7 drinks in 24 hrs).
- Treatment with drugs known to influence glucose metabolism (other diabetes medications, systemic glucocorticoids, pharmacologic doses of niacin)
- Hypersensitivity to metformin or any component of the formulation
Data sourced from ClinicalTrials.gov (NCT02432287). 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. Informational only — not medical advice.