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Current Research Studies

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For more information, call 210-358-7000.
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
  • Age > 18 yrs
  • Good general health other than diabetes
  • Poor glycemic control with HbA1c > 7.0% and < 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

This study will enroll approximately 120 study participants with Type 1 diabetes.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


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

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


ADA Pre-Diabetes StudyHSC 20130414/P20372
Principal Investigators: Drs. DeFronzo/Cersosimo/Curtis Triplitt

Purpose: Preservation of beta function in pre-diabetes in subject with impaired fasting glucose (IFG) and impaired glucose tolerance (IGT).

Eligibility:

  • Ages 18-65
  • Pre-Diabetics with HbA1c > 5.7% and < 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 clinical trial study.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


Triple Therapy Study – HSC20080456H
Principal Investigators: Dr. DeFronzo

Purpose: To compare the efficacy of two different therapeutic regimens for the treatment of individuals with newly diagnosed diabetes.

Eligibility:

  • Newly diagnosed (<2 years) Type 2 diabetes
  • May be taking metformin

This study will enroll approximately 600 study participants with Type 2 diabetes, and it will continue for a period of 3 years.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


AZ Dapa-Exenatide (P4) – HSC20160597H/P20693
Principal Investigators: Drs. DeFronzo and Eugenio

Purpose: To examine the effect of chronic exenatide (4 months) therapy on beta cell function and insulin sensitivity and the role it plays to decrease the elevation in plasma glucagon level observed in SGLT2 inhibition.

Eligibility:

  • Type 2 diabetes with HbA1c > 7.0% and < 10.0%
  • Age: 18-70 years
  • BMI: 21-45 kg/m^2; males or females
  • Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, lipids, urinalysis, urine albumin/creatinine ratio and EKG
  • Stable body weight +/- 3 lbs. within the last 3 months
  • Subjects not in an excessively heavy exercise program
  • May be taking no medications or on metformin and/or sulfonyluria for at least 3 months

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


Hyperfiltration Study – HSC20160262H/P20602
Principal Investigators: Drs. Cersosimo and DeFronzo

Purpose: To examine effect of farxiga on renal function and size in Type 2 diabetic patients with hyperfiltration.

Eligibility:

  • Drug naïve, metformin-treated, or sulfonylurea-treated patients with Type 2 diabetes
  • BMI: 20.0-45 kg/m^2
  • A1C: 7-12%
  • Hct: >34
  • BP: <140/90

This study will enroll approximately 80 study participants with Type 2 diabetes.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


Norepinephrine Labeled Study – HSC20170214H/P20799
Principal Investigators: Dr. M Abdul-Ghani

Purpose: To examine the effect of empagliflozin on endogenous glucose production and the role of the autonomic nervous system in mediating this increase in endogenous glucose production in response to glucosuria caused by the drug.

Eligibility:

  • Good general health
  • Drug naïve or taking metformin only (Type 2 diabetes)
  • FPG < 240 mg/dl
  • Age 18-65 years
  • Hematocrit > 34%
  • eGFR > 60 ml/min
  • Stable weight +/-4 lbs. within the last 3 months

This study will enroll approximately 36 study participants with Type 2 diabetes.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


VICERAL Lipectomy Study – HSC20190476H/P20931
Principal Investigators: Drs. R. DeFronzo, Co Sub I Carolina Solis-Herrera

Purpose: Investigational mesenteric visceral lipectomy for Type 2 diabetes (IMVL-T2D :1 year safety & efficacy study).

Eligibility:

  • Type 2 diabetes with HbA1c > 8.0% and < 10% taken within 30 days pre-op
  • Age: 22-75 years (Caveat: premenopausal women are excluded)
  • BMI: 30-39.9 kg/m^2; males or females
  • Diagnosis of Type 2 diabetes, 10 years or less in duration
  • In good general health except for being diagnosed as having Type 2 diabetes & in good enough general health to undergo a conversion from a mini- laparotomy incision to an open laparotomy incision if that conversion becomes necessary during the operative procedure
  • Subject has poorly controlled Type 2 diabetes and is on a current regimen of at least two oral hypoglycemic agents, the first medication dosed at the maximum dose, and the second dosed at the minimum or higher labelled dose
  • Treatment regime does not include insulin treatment
  • Able to have MRI examinations

This study will enroll approximately 12 study participants with Type 2 diabetes.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


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.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


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)

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

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


Keto-Diet Study – HSC20200230H/P21064

Purpose: To examine the effects of Ketogenic Diet on Glucose Metabolism and Energy Expenditure in patients with type 2 diabetes.

Eligibility:

  • Type 2 diabetes with HbA1c > 7.0% and < 10.5%
  • Age: 18-70 years
  • BMI: 27.5-42 kg/m^2; males or females
  • Currently on treatment with Metformin, Sulfonylureas and DPP4 Inhibitor only
  • Blood pressure < 145/85mmHg
  • No eGFR > 60ml/min/1.73 m2
  • No Hematocrit < 34
  • No contraindication for MRI (metal plates, parts, screws, shrapnel, pins in the body or cardiac pacemaker)
  • Stable weight +/- 4 to 5 lbs. within the last 3 months
  • In good general health

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


Norepinephrine Labeled Study – HSC20170214H/P20799
Principal Investigators: Dr. M Abdul-Ghani

Purpose: To examine the effect of empagliflozin on endogenous glucose production and the role of the autonomic nervous system in mediating this increase in endogenous glucose production in response to glucosuria caused by the drug.

Eligibility:

  • Non-diabetic
  • Good general health
  • FPG < 126 and 2-h PG < 200 mg/dl
  • Age 18-65 years
  • Hematocrit > 34%
  • eGFR > 60 ml/min
  • Stable weight +/-4 lbs. within the last 3 months

This study will enroll approximately 36 study participants with no diabetes.

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.


Treatment of NAFLD Study – HSC20210284H/P21137

Purpose: To examine the quantifying hepatic mitochondrial fluxes in humans.

Eligibility:

  • Non-diabetic
  • Good general health
  • Age 18-75 years
  • HbA1c < 5.5%
  • BMI=25-40 kg/m2
  • Stable weight +/-4 lbs. within the last 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

If you would like more information on this research study or have questions about TDI diabetes research, please call 210-358-7200.



Doctors
  1. Carolina Solis-Herrera, MD
    Carolina Solis-Herrera, MD
    Endocrinology
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  2. Devjit Tripathy, MD
    Devjit Tripathy, MD
    Endocrinology
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  3. Marzieh Salehi, MD
    Marzieh Salehi, MD
    Endocrinology
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