Protocol lV: SGLT2 Inhibitors, Pioglitazone and Ketone Production in Type 2 Diabetes Mellitus
The University of Texas Health Science Center at San Antonio
Summary
To examine whether the empagliflozin-induced stimulation of EGP, lipolysis, and ketone production in T2D individuals can be blocked by pioglitazone (which has direct hepatic and adipose tissue effects).
Description
Participants: 64 T2D subjects with the same inclusion and exclusion criteria as Protocol 1. Subjects with hematuria are excluded. Study Design: Infusions of 3-3H-glucose and 14C-glycerol are started and continued to study end (2 PM). Baseline blood samples for HbA1c (x2) and for plasma insulin, glucagon, glucose, FFA, BHB, AcAc, glycerol, and plasma 3-3H-glucose and 14C-glycerol specific activities are drawn at -30, -20, -10, -5, and 0 minutes for measurement of lipolysis, ketone production (plasma ketone levels), and EGP. Empagliflozin (25 mg) is ingested at time zero (9AM) and plasma sample…
Eligibility
- Age range
- 30–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ages 30-75 * BMI (Body Mass Index) 21-45 kg/m2 * HbA1c = 7.0-11% * eGFR (estimated glomerular filtration rate)\> 60 ml/min/1.73m2 * Blood Pressure (BP)≤160/90 mmHg * Participants must be in general good health based on medical history, physical exam, screening blood chemistries, CBC (Complete Blood Count), TSH/T4 (thyroid/thyroxine hormone), EKG (electrocardiogram), and urinalysis (UA) * Stable body weight (±1.5 kg) over the last 3 months and must not participate in an excessively heavy exercise program * Patients treated with diet, Sulfonylureas, Metformin, or Sulfonylu…
Interventions
- DrugEmpagliflozin 25 MG
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.
- DrugPioglitazone 15 mg increased to 30 mg after 2 weeks plus Empagliflozin Placebo
Placebo-Inert tablet
- DrugEmpagliflozin 25 mg/d plus Pioglitazone (15/30 mg/d)
Pioglitazone, a medication used in the management and treatment of type 2 diabetes mellitus. It is in the thiazolidinedione class of medications
Location
- Texas Diabetes Institute/UHSan Antonio, Texas