Current Research Studies
Find a diabetes-related research study to participate in at University Health in San Antonio.
We are currently conducting the following studies:
Current 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 mary.samano@uhtx.com
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 mary.samano@uhtx.com
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 mary.samano@uhtx.com
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 mary.samano@uhtx.com
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 mary.samano@uhtx.com
Corcept Therapeutics / “Study of Hypercortisolism in Patients with Difficult to Control Type 2 Diabetes Despite Receiving Standard-of-Care Therapies: Prevalence and Treatment with Korlym® (Mifepristone) (CATALYST)” – HSC20230158H/P21368
Principal Investigator: Dr. Ralph
Inclusion Criteria:
- You are between 18 and 80 years old
- You have been diagnosed with type 2 diabetes (T2D)
- Your recent hemoglobin A1c (HbA1c) level is between 7.5 and 11.5%
- For your T2D you are currently taking:
- 3 or more medications, or
- Insulin plus other medications, or
- 2 or more medications and have complications of T2D and/or have high blood pressure requiring 2 or more medications.
- You are agreeable to the testing procedures described below
- If you are taking oral contraceptive pills (OCPs), you are willing to stop them for 3 weeks prior to the initial blood testing
**This is a two-part study: Part 1, which is what you are consenting to, will screen a large number of participants with difficult to control T2D in order to determine how often high cortisol levels are present in this population. In Part 1, you will not receive any study treatment and you will continue your current treatments for T2D. Part 2, which you may be eligible for, examines whether study treatment to lower the effects of high cortisol will help to treat participants with high cortisol levels who have difficult to control T2D. The Sponsor makes a US Food and Drug Administration (FDA)-approved study drug that is one of the available study treatments. You do not need to agree to participate in Part 2 to be able to participate in Part 1 of the study. However, to be considered for Part 2, you must participate in Part 1.** (Part 2 about 28 week study)
(Study Coordinators: Curtiss Puckett, PA-C, Josh Falcon, NP, Cynthia Ramirez, LVN)
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 mary.samano@uhtx.com
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 mary.samano@uhs-sa.com
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 mary.samano@uhtx.com
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 mary.samano@uhs-sa.com
