SGLT2 Inhibition in Older Obese Adults With Pre-diabetes

  • STATUS
    Recruiting
  • End date
    Aug 25, 2023
  • participants needed
    20
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 25 January 2021
diabetes
body mass index
blood sugar
hemoglobin a1c

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.

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 mitochondrial respiration, and the development of pro-inflammatory senescent cells. Developing and testing interventions that interact with multiple points of this spectrum may delay the aging process. Based on prior investigations, the study team believe the SGLT2 inhibitor class of drugs may target these basic mechanisms involved in the aging process and propose testing in a high-risk human population to evaluate their effectiveness in ameliorating aging-associated dysfunctions. Specifically, the investigators hypothesize that SGLT2i drugs will lead to reductions in oxidative damage to DNA and proteins, AGE-RAGE, and cellular senescence, which will be accompanied by improvements in mitochondrial function. If the hypothesis is correct, these findings could lead to the development of new approaches to increase both health-span and lifespan.

This is a single center, open-label, randomized controlled trial. The target enrollment for this pilot study is 20 completed subjects, split evenly between experimental and control groups. Each subject will be randomized to either the experimental group of dapagliflozin 10mg daily for 12 weeks or the control group of nutritional counseling for weight loss. Health-span and clinical evaluations will be taken at baseline and at weeks 10-12 of the study.

Details
Condition Senility, Aging
Treatment Nutritional counseling, Dapagliflozin 10 mg
Clinical Study IdentifierNCT04401904
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 60 yrs?
Gender: Male or Female
Do you have any of these conditions: Senility or Aging?
Do you have any of these conditions: Aging or Senility?
Men or post-menopausal women
Age= 60+ years
All ethnic groups
Body Mass index (BMI) between 30-37 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 Criteria

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)
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