SGLT2 Inhibition in Older Obese Adults With Pre-diabetes

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT04401904
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin 10 mg — DRUG
    10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth
  • Nutritional counseling — BEHAVIORAL
    10 participants randomized to receive 12 weeks of weekly counseling on nutrition

Study Details

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.

Key Dates

Start date
Jun 25, 2020
Status verified
Jan 2024
Primary completion
Sep 14, 2022
Completion
Sep 14, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Dapagliflozin
    10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.
  • Other: Nutritional Counseling
    10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks

Primary Outcome Measure

AGE-RAGE Measurement in Plasma [ Time Frame: Baseline to 12 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Texas Diabetes Institute - University Health SystemSan AntonioTexas78207-
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

Find similar trials in San Antonio, TX

By research site
Texas Diabetes Institute - University Health System· San Antonio, TXUniversity of Texas Health Science Center at San Antonio· San Antonio, TX

Related Studies