Current Research Studies

Adult JDFR Diabetes Type 1 Study – HSC20180515H/P20902

Principal Investigators: Dr. M Abdul-Ghani

Purpose: To investigate whether the addition of pioglitazone to SGLT2 inhibitor in Type 1 diabetic patients can amplify the decrease in HbA1C and prevent the increase in plasma ketone concentration.

Eligibility:

• Type 1 diabetes mellitus
• Age > 18 yrs
• Good general health other than diabetes
• Poor glycemic control (HbA1C 7.0-11.0%)
• Treatment with multiply daily insulin injects or insulin pump
• Total daily insulin dose > 0.6 units/kg/daily
• Stable insulin dose in the preceding 3 months
• eGFR > 60 ml/min
• Stable weight in the preceding 3 months

(Study coordinator: Gozde)

This study will enroll approximately 120 study participants with Type 1 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

JDFR Diabetes Type 1 Study

Principal Investigators: Drs. M Abdul-Ghani and R. DeFronzo

Purpose: To examine the effect of addition of combination therapy with dapagliflozin plus pioglitazone to insulin on glucose control and plasma ketone concentration in patients with type 1 diabetes.

Eligibility:

• 18 years or older
• Have uncontrolled blood sugar (HbA1c > 7%)
• In good general health
• Have normal kidney function
• Take more than 40 units of insulin each day

*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

ADA Pre-Diabetes Study – HSC 20130414H/P20372 Ongoing study/enrolling subjects

Purpose: Preservation of Beta Function in pre-diabetes in subject with Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT).

Principal Investigator: Drs DeFronzo/Chavez /Curtis Triplitt

Eligibility:

• ages 18-65
• Pre-Diabetics (A1C 5.7-6.4) or
• Normal Healthy subjects without Family History of diabetes in a first-degree relative.
• BMI=24-40 kg/m2
• Stable body weight
• Able to take oral medications

A 2 year long clinical trial study.

(Study Coordinator: Josh Falcon NP, Cynthia Ramirez)

*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 Investigators: 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, Jessica Falcon, RN)

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: Gozde Baskoy, Papanun (Gift) Mahapol)

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, muscle metabolism- HSC00000012/P21411

Principal Investigators: Dr. R 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:

• 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 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) Qin, Siva Neppala MD, Jemema Rajan MD)

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

ADA Pre-Diabetes Study – HSC 20130414H/P20372 Ongoing study/enrolling subjects

Principal Investigator: Drs DeFronzo/Chavez /Curtis Triplitt

Normal Healthy Volunteers/ Without Diabetes

Eligibility:

• ages 18-65
• Pre-Diabetics (A1C 5.7-6.4) or
• Normal Healthy subjects without Family History of diabetes in a first-degree relative.
• BMI=24-40 kg/m2
• Stable body weight

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

Bio89-100-231, A phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pegozafermin in Subjects with Severe Hypertriglyceridemia (SHTG)

Principal Investigator: Ralph Defronzo

Inclusion Criteria:

• Males or non-pregnant females at least 22 years of age
• Mean of 2 screening fasting serum TGs ≥ 500 to ≤ 2000 mg/dL at least 7 days apart
• History of elevated TGs ≥ 400 in the last 5 years
• Willing to enter the lifestyle optimization period and to maintain stable eating and exercise habits for the duration of the study.
• Subjects should be on a stable background of care LMT (statins, fibrates, cholesterol absorption inhibitors, niacin, and prescription fish oil treatment, and should be clinically stable for ≥ 4 weeks
• Subject is willing to refrain from alcohol consumption for ≥ 48 hours before each study visit
• Medicines known to exacerbate hypertriglyceridemia (such as beta blockers, thiazides, estrogens, bile acid sequestrants, protease inhibitors and isoretinoin) should be stable (≥ 4 weeks before screening V1).

(Study Coordinators: Cynthia Ramirez, LVN, Curtiss Puckett, PA-C, Josh Falcon, NP)

*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