Current Research Studies

Can Pioglitazone block SGLT2 Inhibitor-induced stimulation of lipolysis, ketone production and liver glucose production in Type I Diabetic Patients - STUDY001633/P21617

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 - STUDY00000139/P21499

Principal Investigators: Muhammad Abdul-Ghani and Dr. Ralph A. DeFronzo

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, Jeannette Worley, RN, 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   

Treatment of NAFLD Study - HSC20210284H/P21137

Principal Investigator: Dr. Ralph A. 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

SGLT2 Inhibitors, Ketogenesis, and Ketoacidosis - HSC20230457H/P21374

Principal Investigator: Dr. Ralph A. DeFronzo

Ongoing study/enrolling subjects

Purpose: Examine the mechanisms by which medication Empagliflozin a Sodium-glucose Cotransporter inhibitors (SGLT2i) induce increases in ketone production and liver glucose production in Type 2 Diabetes (T2D) individuals.

Eligibility:

• T2DM with HbA1c > 6.5% and < 10.5%
• Age: 30-75 years
• BMI: 21-45 kg/m^2; males or females
• Treated with diet alone and/or Metformin and/or Sulfonylureas and/or Metformin + Sulfonylureas
• No treatment with GLP-1RA, DPP4i, pioglitazone, SGLT2i or insulin
• Blood pressure < 145/85mmHg
• eGFR > 60ml/min/1.73 m2

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

*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 mary.samano@uhs-sa.com

Glycemic and weight loss effects of GLP-1R agonist therapy in subjects with spinal cord injury and type 2 diabetes - STUDY591/P21465

Principal Investigator: Drs. Marzieh Salehi and Michelle Trobovich

Ongoing study/enrolling subjects

Purpose: To investigate the effect of semaglutide medication on aspects of glucose regulation and other factors related to type 2 diabetes and obesity in people with spinal cord injuries. .

Eligibility:

• Diagnosed with type 2 diabetes
• Diagnosed with a spinal cord injury
• Not Currently taking medications for weigh loss (Wegovy, Ozempic or Phentermine)
• Ages 18-70

(Study Coordinator: Jessica Pena, Noelle Vinson, or Mooney Mark-Johnson)

*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 mary.samano@uhs-sa.com

Quantifying Hepatic Mitochondrial Fluxes in Humans – Treatment of NAFLD - HSC20210284H/P21137

Principal Investigator: 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 Hewitt/Taylor Belinowski/Curtiss Puckett)

*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 mary.samano@uhs-sa.com

SGLT2 inhibitors, Ketones, Muscle Metabolism (Heart failure study) - STUDY00000012/P21411

Principal Investigator: Dr. Ralph A. DeFronzo

Ongoing study/enrolling subjects

Purpose: 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:

71 subjects

• T2DM 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
• BMI: 23-44 kg/m^2; males or females
• No treatment DPP4i, pioglitazone, SGLT2i
• Blood pressure <145/85mmHg
• eGFR>30ml/min/1.73 m²
• No contraindication for MRI (metal plates, parts, screws, shrapnel, pins in the body, or cardia pacemaker)

(Study Coordinators: Jane (Yuejuan) Qin, Cynthia Ramirez RN, Eugene Feigin)

*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 mary.samano@uhs-sa.com

Glycemic and weight loss effects of GLP-1R agonist therapy in subjects with spinal cord injury and type 2 diabetes - STUDY591/P21465

Principal Investigator: Drs. Marzieh Salehi and Michelle Trobovich

Ongoing study/enrolling subjects

Purpose: To investigate the effect of semaglutide medication on aspects of glucose regulation and other factors related to type 2 diabetes and obesity in people with spinal cord injuries. .

Eligibility:

• Diagnosed with type 2 diabetes
• Diagnosed with a spinal cord injury
• Not Currently taking medications for weigh loss (Wegovy, Ozempic or Phentermine)
• Ages 18-70

(Study Coordinator: Jessica Pena, Noelle Vinson, or Mooney Mark-Johnson)

*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 mary.samano@uhs-sa.com

The role of glucagon in glucose metabolism in humans with and without bariatric surgery - STUDY1597/P21603

Principal Investigator: Dr. Marzieh Salehi

Ongoing study/enrolling subjects

Purpose: To examine how the body regulates blood sugar after eating in individuals with bariatric surgery. This study uses an investigational medication to better understand how insulin and glucagon affect glucose levels. Findings may help improve future treatments for blood sugar control and metabolic health.

Eligibility:

• Have had bariatric surgery (gastric bypass (RYGB), gastric sleeve) and have no diabetes
• Have had bariatric surgery and experience low blood sugar symptoms (feeling shaky, sweaty, dizzy, confused) as a result of bariatric surgery
• Generally healthy

(Study Coordinators Jessica Pena, Noelle Vinson, and Mooney Mark-Johnson)

*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 mary.samano@uhs-sa.com