CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Dapagliflozin 10 mg +1 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04401904
NCT04401904Phase 2Completed

Effect of SGLT2 Inhibition on Aging-related Biomarkers in Older Obese Adults With Pre-diabetes

The University of Texas Health Science Center at San Antonio·interventional·Posted May 26, 2020·Updated Jan 5, 2024

In Brief

A Phase 2 clinical trial evaluating Dapagliflozin 10 mg and Nutritional counseling for Aging. Completed, enrolled 20 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAging
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 26, 2020
Enrollment StartJun 25, 2020
Primary CompletionSep 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.1 years ago

Interventions

Dapagliflozin 10 mgdrug

10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth

Nutritional counselingbehavioral

10 participants randomized to receive 12 weeks of weekly counseling on nutrition