| Trial ID: | L6235 |
| Source ID: | NCT05960656
|
| Associated Drug: |
Empagliflozin 25 Mg
|
| Title: |
SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes|Type 1 Diabetes
|
| Interventions: |
DRUG: Empagliflozin 25 MG|OTHER: Placebo|DRUG: Pioglitazone 30mg|DRUG: Pioglitazone 30mg + Empagliflozin (25 mg)
|
| Outcome Measures: |
Primary: Endogenous Glucose Production (EGP), Measurement of Endogenous Glucose Production (EGP) using stable isotope (6,6, D2- glucose infusion)., 0 and 300 minutes|Ketone Body Turnover (ketogenesis), The rate of ketogenesis will be determined by infusion of stable isotope 13C palmitate and quantitating the enrichment of 13C in 3-hydroxybutyrate (b-OHB)., 0 and 300 minutes|Hemoglobin A1c (HbA1c), Measurement of a person's average blood sugar levels over the past two to three months, Baseline and week 10 (Study 4 and Study 5)|Norepinephrine turnover, Measurement of norepinephrine turnover using 3H-norepinephrine, 0 and 300 minutes | Secondary: Plasma Insulin Concentration, Change in concentration of plasma insulin during the study, 0 and 300 minutes|Plasma Free Fatty Acids (FFA), Change in concentration of free fatty acids during the study, 0 and 300 minutes|Plasma glucose concentrations, Change in concentration of plasma glucsoe during the study, baseline and week 10 (Study 4 and Study 5)
|
| Sponsor/Collaborators: |
Sponsor: The University of Texas Health Science Center at San Antonio | Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
EARLY_PHASE1
|
| Enrollment: |
169
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2023-10-05
|
| Completion Date: |
2027-06-30
|
| Results First Posted: |
|
| Last Update Posted: |
2024-07-10
|
| Locations: |
Texas Diabetes Institute/UH, San Antonio, Texas, 78229-3900, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05960656
|
