Status:
COMPLETED
SGLT2 Inhibition in Older Obese Adults With Pre-diabetes
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Aging
Eligibility:
All Genders
60+ years
Phase:
PHASE1
PHASE2
Brief 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 seconda...
Detailed Description
Investigations into the aging process have identified major cellular dysfunctions that contribute to aging, including but not limited to increased burden of damaged DNA and protein, reduction in mitoc...
Eligibility Criteria
Inclusion
- 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
- Diagnosis of diabetes based on American Diabetes Association (ADA) 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%
- Abnormal triglycerides with upper limits ≥600 mg/dL
- Abnormal Thyroid stimulating hormone (TSH) values ≤0.3 and ≥10
- Urinalysis results with ˃ 5-10 white blood cell count
- Concomitant medications known to affect glucose and lipid homeostasis (anti-diabetes medications, glucocorticoids, atypical antipsychotics, anti-transplant rejection medications, anti-retrovirals).
- Current treatment with anticoagulants (warfarin). Aspirin (up to 325 mg) and clopidogrel will be permitted if these can be held for seven days prior to the biopsies.
- History of recent cardiovascular event in the last 6 months or Heart Failure (New York Heart Classification greater than class III-IV; recent EKG changes that suggest active heart disease
- Poorly controlled blood pressure (systolic BP\>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
Key Trial Info
Start Date :
June 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 14 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04401904
Start Date
June 25 2020
End Date
September 14 2022
Last Update
January 5 2024
Active Locations (2)
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1
Texas Diabetes Institute - University Health System
San Antonio, Texas, United States, 78207
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229