Phase 2
Completed N=20
SGLT2 Inhibition in Older Obese Adults With Pre-diabetes
Source: ClinicalTrials.gov NCT04401904 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcomePrimary: AGE-RAGE Measurement in Plasma — -172; -86 pg/mL
Summary
Inhibitors of the sodium-glucose co-transporter (SGLT2) are FDA-approved for the treatment of type 2 diabetes (T2DM). Their mechanism of action involves lowering of blood glucose concentration secondary to increased glucose excretion of glucose by the kidney. These drugs also improve body weight, blood pressure, and cardiac function. Based on these pleiotropic effects, including its calorie restriction-mimetic properties, the study team hypothesize that SGLT2 drugs will impact several basic aging-related processes, including reductions in oxidative damage to DNA and proteins, advanced glycation end products (AGE) and receptor for AGE (RAGE), cellular senescence, and mitochondrial function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AGE-RAGE Measurement in Plasma |
-172; -86 | — |
| SECONDARY Grip Strength |
-2; -1 | — |
| SECONDARY 6 Minute Walking Distance |
6.6; 9.1 | — |
Eligibility Criteria
Inclusion Criteria
- Men or post-menopausal women.
- Age= 60+ years.
- All ethnic groups.
- Body Mass index (BMI) between 30-38 kg/m2.
- Diagnosis of pre-diabetes (HbA1c 5.7-6.4% and 2 hr. Oral Glucose Tolerance Test (OGTT) glucose between 140-199 mg/dL, evaluated at Visit 1 and 2).
- Stable body weight (±3% for ≥3 months).
- Willing to adhere to medication regimen for three months.
- Montreal Cognitive Assessment score ≥21
Exclusion Criteria
- Diagnosis of diabetes based on American Diabetes Association (ADA) criteria
- Impaired renal function with estimated Glomerular Filtration Rate (eGFR) 180, diastolic BP>100 mmHg).
- Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, and uncontrolled psychiatric disease (Subjects with depression, anxiety, PTSD, etc. can enroll if controlled and on stable medication)
- Blood donation within 2 months prior to enrollment
- History of frequent UTI
Data sourced from ClinicalTrials.gov (NCT04401904). 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.