Current Research Studies

Can Pioglitazone block SGLT2 Inhibitor-induced stimulation of lipolysis, ketone production and liver glucose production in Type I Diabetic Patients - STUDY001633/P2137

Principal Investigators: Muhammad Abdul-Ghani

Ongoing study/enrolling subjects

Purpose: To investigate the mechanistic pathways underlying sodium-glucose cotransporter 2 (SGLT2) induced changes in hepatic glucose production and ketogenesis in individuals with T1DM and evaluate whether pioglitazone can mitigate these effects.

Eligibility:

Age >18 years

• Type 1 Diabetes
• Other than diabetes, subjects must be in good general health as determined by the investigator based on physical exam, medical history and screening labs.
• Fasting C-peptide concentration <0.7 ng/ml
• (HbA1c=7.0-11.0%)
• Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump (Total daily insulin dose ≥0.6 U/kg per day)
• Total daily insulin dose ≥0.6 U/kg per day
• Stable insulin dose (±4 units) in the preceding three months
• eGFR ≥ 50 ml/min
• Weight stable over the preceding 3 months (± 4 pounds)

(Study Coordinators: Aurora Merovci, MD, MPH & Danielle Aquino, RN)

*Subjects receive study visits, follow-up by physicians, laboratory tests, blood glucose monitoring supplies, electrocardiograms, and study related medications free of charge. Also, they receive compensation for time, transportation (if needed), and study meals free of charge.

For information, please call 210-358-7200 and ask to speak with one of the research nurses or investigators; or you may send an email message to diabetes-research@uthscsa.edu

Comparative Effectiveness of Two Initial Combination Therapies in Patients with New Onset Diabetes

Principal Investigators: Muhammad Abdul-Ghani

Ongoing study/enrolling subjects

Purpose: To examine the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus (T2DM) patients.

Eligibility:

• 512 subjects
• Males or females
• Age 18-75 years
• Recently diagnosed T2DM (within 5 years)
• Drug naïve or receiving metformin monotherapy
• HbA1C >6.5% (no limit on upper HbA1c value)
• Stable body weight over the preceding 3 months
• Good general health
• Agreement to adhere to Lifestyle Considerations throughout study duration

(Study Coordinators: Erwin Nepomuceno, APRN,  Papanun (Gift) Mahapol, Hussein Zaitoon)

For information, please call 210-358-7200 and ask to speak with one of the research nurses or investigators; or you may send an email message to diabetes-research@uthscsa.edu 

Non-Alcoholic Fatty Liver Disease Study

Principal Investigators: Drs. Luke Norton and Ralph DeFronzo

Purpose: To understand the role that mitochondria - often referred to as the powerhouse of the cell - play in the development and progression of fatty liver disease in patients with type 2 diabetes.

Eligibility:

• 18-75 year old people with or without diabetes
• Enrolling healthy controls without diabetes
• Enrolling T2DM subjects with fatty liver
• Will receive free evaluation of fatty liver status in the study.

*Subjects receive study visits, follow-up by physicians, laboratory tests, blood glucose monitoring supplies, electrocardiograms, and study related medications free of charge. Also, they receive compensation for time, transportation (if needed), and study meals free of charge.

For information, please call 210-358-7200 and ask to speak with one of the research nurses or investigators; or you may send an email message to diabetes-research@uthscsa.edu

SGLT2 Inhibitors, Ketones & Cardiovascular Benefit Study – HSC20210528H/P21168

Principal Investigators: Drs. Carolina Solis-Herrera, E Cersosimo, and R DeFronzo

Purpose: To examine the effects of SGLT2i (and SGLT2i –induced increase in plasma ketone concentrations) on skeletal muscle and cardiac ketone uptake, skeletal muscle bioenergetics, cardiopulmonary exercises capacity, and patient-reported functional outcomes.

Eligibility:

• Type 2 diabetes with HbA1c > 6.0% and < 10.0%
• Class II-III New York Heart Association heart failure with ejection fraction less than 45%
• Age: 18-80 years
• BMI: 23-38 kg/m^2; males or females
• No treatment with GLP-1RA, DPP4i, pioglitazone, SGLT2i or insulin
• Blood pressure < 145/85mmHg
• eGFR > 30ml/min/1.73 m2
• No contraindication for MRI (metal plates, parts, screws, shrapnel, pins in the body or cardiac pacemaker)

(Study Coordinators: Jane (Yuejuan)

This study will enroll approximately 71 study participants with Type 2 diabetes.

*Subjects receive study visits, follow-up by physicians, laboratory tests, blood glucose monitoring supplies, electrocardiograms, and study related medications free of charge. Also, they receive compensation for time, transportation (if needed), and study meals free of charge.

For information, please call 210-358-7200 and ask to speak with one of the research nurses or investigators; or you may send an email message to diabetes-research@uthscsa.edu 

Treatment of NAFLD Study – HSC20210284H/P21137

Principal Investigator: Dr. R. DeFronzo and Dr. Luke Norton

Purpose: To establish a minimally invasive method to quantitate hepatic mitochondrial in human subject’s in vivo using stable isotope tracers coupled to 2H and 13C NMR analyses, quantitate hepatic mitochondrial fluxes in control and T2D patients with NAFLD, and examine the impact of pioglitazone treatment on mitochondrial fluxes in patients with NAFLD. These studies are designed to generate preliminary data that will facilitate larger clinical studies designed to interrogate the role of hepatic mitochondrial function in the development, progression and treatment of NAFLD and related disorders.

Eligibility:

• Good general health
• Age 18-75 years
• HbA1c < 5.5%
• BMI=25-40 kg/m2
• Stable body weight (±4 pounds) over the preceding 3-months
• Not taking any medication known to affect glucose metabolism
• No evidence of T2D, (IFG; FPG ≥ 100 > 126 mg/dl) OR (IGT; 2 h OGTT glucose ≥ 140 > 200 mg/dl)
• No evidence of fatty liver on FibroScan or
• Evidence of moderate/severe fatty liver on FibroScan

(Study Coordinator: Michael/Curtiss Puckett PA/Terry Bakewell)

*Subjects receive study visits, follow-up by physicians, laboratory tests, blood glucose monitoring supplies, electrocardiograms, and study related medications free of charge. Also, they receive compensation for time, transportation (if needed), and study meals free of charge.

For information, please call 210-358-7200 and ask to speak with one of the research nurses or investigators; or you may send an email message to diabetes-research@uthscsa.edu

Pioglitazone, Lipotoxicity and Heart Failure with Preserved Ejection Fraction (HFpEF) – HSC20230158/P21368

Principal Investigators: Dr. Ralph A. DeFronzo

Purpose: To see the effects on Pioglitazone on skeletal and myocardial muscle. Our previous research shows, Pioglitazone Improves insulin sensitivity in skeletal and myocardial muscles, decreases fat in the muscles leading to improved measures of both diastolic and systolic functions of heart in obese, type 2 diabetic patients.

Eligibility: 72 patients

Inclusion criteria:

• Diabetes with HbA1c >6.5
• Needs to be on stable medications for diabetes and heart failure in last 3 months
• Heart failure with EF >50%
• Age 30-70 years
• Blood pressure < 145/90
• eGFR >45 ml/min/1.73m2
• No contraindication to MRI (metal plates, pacemaker or pins or needles)
• Do not suffer from Claustrophobia
• Not pregnant or breast feeding
• Weight stable in last 3 months

(Study Coordinator: Sivaram Neppala MD)

*Subjects receive study visits, follow-up by physicians, laboratory tests, blood glucose monitoring supplies, electrocardiograms, and study related medications free of charge. Also, they receive compensation for time, transportation (if needed), and study meals free of charge.

For information, please call 210-358-7200 and ask to speak with one of the research nurses or investigators; or you may send an email message to diabetes-research@uthscsa.edu