SGLT2 Inhibition in Older Obese Adults With Pre-diabetes

(SGLT2i Trial)

Recruiting at1 trial location

Overseen by Carolina Solis-Herrera

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: The University of Texas Health Science Center at San Antonio

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Carolina Solis-Herrera

Principal Investigator

University of Texas Health at San Antonio

Eligibility Criteria

Inclusion Criteria

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).

Age= 60+ years.

People of all races and ethnicities are welcome to participate.

Exclusion Criteria

Impaired renal function with estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73m2

Impaired liver function with labs ≥3 times upper limits of normal range

Abnormal hematocrit with lower limits of ≤30%

Treatment Details

Interventions

• Dapagliflozin 10 mg (SGLT2 Inhibitor)
• Nutritional counseling (Behavioral)

Participant Groups

Group I: Nutritional Counseling Experimental Treatment 1 Intervention

10 participants with pre-diabetes will be randomized to receive nutritional counseling weekly for 12 weeks

Group II: Dapagliflozin Experimental Treatment 1 Intervention

10 participants with pre-diabetes will be randomized to the experimental group to receive dapagliflozin 10mg by mouth daily for 12 weeks.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Dr. Andrew Masica

The University of Texas Health Science Center at San Antonio

Chief Medical Officer

MD from Indiana University School of Medicine

Dr. Taylor Eighmy

The University of Texas Health Science Center at San Antonio

Acting President

PhD in Civil Engineering from the University of New Hampshire

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School