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Sodium-glucose Co Transporter 2 (sGLT2) Inhibitor and Endogenous Ketone Production

NCT03852901 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-08-02

Study results available
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Summary

Background:

The drug empagliflozin treats diabetes. It lowers blood sugar by increasing glucose the kidneys excrete. This increases levels of ketones formed in the blood. The body makes ketones when it does not have enough glucose for fuel. The brains of many people with age-related diseases like Alzheimer's do not use glucose well. Brain use of ketones might improve mental ability. We investigated how empagliflozin affects ketone levels, which could lead to ways to improve brain health as people age.

Objectives:

To study how taking empagliflozin affects systemic and brain metabolism including ketone levels in people without diabetes.

Eligibility:

Adults at least 55 years old without diabetes

Design:

After a screening Visit, eligible participants were admitted to the NIA Clinical Unit during Visits 1 (baseline), 2 (first dose) and 3 (last/14th dose). On each Visit, blood draws were performed and circulating metabolites and hormones were repeatedly measured over 34-hour periods. Using plasma from fasting state only, we isolated total and neuronal-origin extracellular vesicles to measure proteins of the IGF-1 and insulin signaling cascades. Furthermore, on each Visit, we performed magnetic resonance spectroscopy (MRS) to measure concentrations of a plethora of metabolites in the brain. Between Visits 2 and 3, participants were taking the drug at home. A continuous glucose monitoring device was placed to detect potential glucose fluctuations while at home. The study was concluded for participants after the end of Visit 3.

Conditions

  • Empaglifozin
  • Physiological Effects of Drugs
  • Hypoglycemic Agents
  • Sodium-Glucose Transporter 2 Inhibitors

Interventions

DRUG

empagliflozin (Jardiance) 25 mg

Oral empagliflozin 25 mg/day x 14 days

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    lead NIH

Principal Investigators

  • Josephine M Egan, M.D. · National Institute on Aging (NIA)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-28
Primary Completion
2020-11-12
Completion
2021-12-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03852901 on ClinicalTrials.gov