SGLT2 Inhibition in Older Obese Adults With Pre-diabetes

NCT04401904 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-01-05

Study results available
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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.

Conditions

  • Aging

Interventions

DRUG

Dapagliflozin 10 mg

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

BEHAVIORAL

Nutritional counseling

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

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Carolina Solis-Herrera · University of Texas Health at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2022-09-14
Completion
2022-09-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04401904 on ClinicalTrials.gov