Intervention: Empagliflozin
Trial phase: Phase 1
ATC code: A10BD19 | A10BD20 | A10BD27 | A10BK03
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(O[C@H]4CCOC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 21
Group description: The single group underwent baseline assessment (visit 1). Fourteen days later (visit 2), participants took the first empagliflozin dose and acute effects were assessed. Participants continued taking empagliflozin once per day at home for 13 additional days, and returned for the final visit (visit 3) in which chronic effects were assessed.
Eligibility criteria:
INCLUSION CRITERIA:

Age 55 years and older.
Healthy (see exclusion criteria below).
Able to understand the study risks and procedures, and consent to participate in the study.
Able to read and speak English.

EXCLUSION CRITERIA:

History of diabetes (requiring any medical treatment other than diet and exercise) or fasting plasma glucose > 126 mg/dl or HbA1c> 6.5 %.
History of hypoglycemia.
BMI > 35 kg/m(2).
Creatinine clearance less than 60 ml/min as measured by GFR.
Glucosuria
History of anemia within the past 6 months or Hgb <11.0 mg/dL for women and Hgb <12.5 mg/dL for men.
Current steroid use or steroid use within 90 days of screening, excluding eye drops.
Currently taking loop diuretics (Lasix, for example).
Participant presently following a calorie restriction diet, low carb/high fat diet.
HIV virus infection
Hepatitis B infection, as evidenced by a positive HBsAG at screen visit.
Hepatitis C infection that has not been treated. (The screen blood work must show HCV RNA quantitative is not detectable).
Active infection/fever that may cause changes in glucose metabolism.
Known allergy to sGLT2 inhibitors in the past.
Thyroid dysfunction that is not controlled or treated. This will be determined by Free T3, T4, Free T4 or TSH not within MedStar Harbor Hospital laboratory normal ranges for this pilot study.
Adrenal dysfunction as determined by a cortisol level not within the normal range for MedStar Harbor Hospital Laboratory for this pilot study.
Kidney or liver disease, (GFR < 60 mL/min/1.73 m(2) and/or liver enzymes not within normal ranges for MedStar Harbor Hospital Laboratory for this pilot study.
Severe gastrointestinal diseases such as Crohn s disease or ulcerative colitis requiring continuous treatment.
History of severe pulmonary disease such as chronic obstructive pulmonary disease (COPD) or asthma requiring continuous medication use.
Patients with known, or evidence of, peripheral vascular disease.
History of chronic urinary tract infections.
History of recurrent or recent dehydration in the past year.
History of recurrent or recent vaginal yeast infection.
Alcohol intake greater than 30 grams (drink more than 2 beers OR equivalent per day).
History of severe psychiatric conditions associated with behavioral problems or requiring chronic medical treatment.
Poor venous access.
Inability to walk 2,000 steps
Donation or loss of 400 mL or more of blood within 56 days prior to and subsequent to screening.
Participation in another study in the past 30 days, in which a study drug was administered.
Currently participating in another study unless the investigator feels it would not interfere with the study.
History of a medical condition or any other reason that, in the opinion of the investigator, will make participation in this study unsafe.
Blood work or urine tests that are not considered by the study physician to be in an acceptable range for the study.
Metal implants and devices incompatible with 3T Magnetic Resonance Imaging (MRI), or another contraindication to MRI.