SGLT2i, Hepatic Glucose Production, and SNS

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT07053293
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 25 MG — DRUG
    A medication used in the management and treatment of type 2 diabetes mellitus. It is in the sodium-glucose co-transporter (SGLT-2) class of medications.

Study Details

In this study, PI will test the hypothesis that distinct mechanisms account for the SGLT2i-induced stimulation of ketogenesis and lipolysis versus endogenous (hepatic) glucose production in patients with type 2 diabetes (T2D) that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. Principal Investigator (PI) will conduct five distinct experiments to test this hypothesis in patients with T2D. To examine the role of the SNS on the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D by comparing the effect of empagliflozin versus empagliflozin plus propranolol.

Key Dates

Start date
Jan 7, 2025
Status verified
Jul 2025
Primary completion
Jun 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin
    Empagliflozin 25 mg/day

Primary Outcome Measure

Endogenous Glucose Production (EGP) [ Time Frame: 0 and 300 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Diabetes Institute/UHSan AntonioTexas78229-3900
Ralph DeFronzo, MD
210-358-7200
Aurora Merovci, MD
210-567-6691
Ralph DeFronzo, MD (PRINCIPAL_INVESTIGATOR)

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