Phase 2
Completed N=32
Effects of Metformin in a Non-Diabetic Patient Population
Inflammatory Response
Source: ClinicalTrials.gov NCT03772964 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: Ex Vivo Cytokine Response of Peripheral Blood Mononucleocytes (PBMC) to Inflammatory Stimuli Compared to Baseline, Throughout Exposure, and Following Exposure to Metformin.
Summary
Metformin has a well-established safety profile and it has become clear that metformin has additional salutary effects, including anti-inflammatory, anti-aging, and anti-thrombotic properties. In this study, subjects will provide both venous blood samples and stool samples in addition to completing cognitive and physiologic testing at baseline, throughout a 90 day exposure to metformin, and 30 days following exposure to metformin in order to evaluate their immune, microbiome, cellular respiration, thrombotic, and inflammatory responses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ex Vivo Cytokine Response of Peripheral Blood Mononucleocytes (PBMC) to Inflammatory Stimuli Compared to Baseline, Throughout Exposure, and Following Exposure to Metformin. |
— | — |
| SECONDARY Quantify the Bacterial Population Profile of the Microbiome Via Stool Samples. |
136.5; 107.6; 128.1; 141.5; 139.9; 130.7 | <0.01 sig |
| SECONDARY Measure the Rate of Clotting of Peripheral Blood With Whole Blood Aggregometry in Response to Collagen. |
56.3; 67; 196; 83.3; -34.7; 8.9 | 0.6057 |
| SECONDARY Measure the Rate of Thrombosis of Peripheral Blood. |
— | — |
| SECONDARY Changes From Baseline in Short Physical Performance Battery (SPPB) During and Following Exposure to Metformin. |
11.2; 10.8; 11.1; 10.6; -0.3; 0.4 | <0.001 sig |
| SECONDARY Changes From Baseline in Grip Strength Via a Dynamometer During and Following Exposure to Metformin. |
28.2; 28.9; 25.7; 25.7; -5.3; -0.4 | 0.69 |
| SECONDARY Mitochondrial Respiration in Both PBMCs and Platelets. |
— | — |
| SECONDARY Mitochondrial Content in Both PBMCs and Platelets. |
— | — |
| SECONDARY Measure Biogenesis of PBMCs. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥55 and ≤85 years of age
- Non-diabetic
- Adjusted risk analysis index (RAI) 20-42
- Estimated glomerular filtration rate >45
- No evidence of hepatic dysfunction on comprehensive metabolic panel
- No clinical evidence of cardiac failure
- Existing University of Pittsburgh Medical Center Patients
Exclusion Criteria
- Hypersensitivity to metformin or any component of the formulation
- Acute or chronic metabolic acidosis with or without coma
- Pregnant or breastfeeding females
- Evidence or history of hepatic, renal, or cardiopulmonary failure
- Excessive acute or chronic ethanol use
- Planned or known hospital admission, exposure to anesthesia, or surgical intervention 30 days prior to study or scheduled 30 days after the trial initiation
- Laboratory analysis showing HbgA1c >6.1 or eGFR <44 on baseline labs
Data sourced from ClinicalTrials.gov (NCT03772964). 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.