SGLTi, Hepatic Glucose Production and Ketogenesis

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05960656
Phase
PHASE1
Status
Recruiting
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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.
  • Placebo — OTHER
    Inert tablet

Study Details

In this study, we 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) and type 1 diabetes (T1D), and that the increases in ketone production and lipolysis can be prevented by concomitant administration of the thiazolidinedione pioglitazone. We will conduct five distinct experiments to test this hypothesis in patients with T2D and T1D. MAIN STUDY: To examine the effect of empagliflozin versus empagliflozin/pancreatic clamp on EGP (6,6, D2-glucose), gluconeogenesis (D2O), lipolysis (U-2H-glycerol), ketogenesis (13C-palmitate conversion to 3-betahydroxybuyrate), and norepinephrine turnover (3H-NE) in type 2 diabetes subjects.

Key Dates

Start date
Oct 5, 2023
Status verified
Jun 2025
Primary completion
Jun 1, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Empagliflozin
    Empagliflozin 25 mg/day
  • Placebo Comparator: Placebo/Control Group
    Placebo control

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
[email protected]
210-358-7200
Aurora Merovci, MD
[email protected]
210-567-6691
Ralph DeFronzo, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Antonio, TX

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Texas Diabetes Institute/UH· San Antonio, TX

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