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
• Age > 18 yrs
• Good general health other than diabetes
• 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.

ADA Pre-Diabetes Study – HSC 20130414
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
• 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.

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

Durability of Early Combination Therapy vs. Conventional Therapy in New Diabetes

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-Pancreatic Study – HSC20160586H/P20685
Principal Investigators: Drs. DeFronzo and Eugenio

Purpose: In this study, the researchers hope to define the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration. We will examine whether the signal for the increase in endogenous glucose production caused by glucosuria is mediated via the decrease in plasma glucose and insulin concentration, or by the increase in plasma glucagon concentration.

Eligibility:

• Type 2 diabetes
• 18-70 years of age
• BMI: 21-45 kg/m^2
• Must be in good general health as determined by physical exam, medical history, blood chemistries, CBC, TSH, T4, EKG and urinalysis
• Stable body weight +/- 3 lbs. over the preceding 3 months
• Subjects not in an excessively heavy exercise program

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%
• 18-70 years of age
• BMI: 21-45 kg/m^2
• 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. over the preceding 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: 20-45
• Hct: >34
• BP: <140/90

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 3-4 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.

Ketones Infusion Study – HSC20180077H/P20833
Principal Investigators: Drs. Carolina Solis-Herrera, E Cersosimo, and R DeFronzo

Purpose: To examine the effects of ketones on heart function, sugar metabolism and blood flow. Recent studies have suggested that ketones may improve heart function and therefore decrease the risk of hospitalization in subjects with heart disease.

Eligibility:

• Type 2 diabetes with HbA1c > 6.0% and < 9.0%
• Class II-III New York Heart Association heart failure with ejection fraction less than 50%
• Age: 30-70 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 > 45ml/min/1.73 m2
• No contraindication for MRI (metal plates, parts, screws, shrapnel, pins in the body, or cardia pacemaker)

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.

Revita-FRACTYL STUDY – HSC20180546/P20855
Principal Investigators: Dr. Ralph A. DeFronzo

Purpose: To evaluate the safety and effectiveness of duodenal mucosal resurfacing using the Revita ™ system in the treatment of Type 2 diabetes.

Eligibility:

• Type 2 diabetic for 3 years or more
• Age 28-65 years old
• A1c= 7.5 – 9.5%
• BMI= 28-40 kg/m2
• On stable dose of metformin and one or two oral diabetic medications for 3 months. No injectable medications accepted. Acceptable sulfonylurea are glipizide or glimepiride (glyburide is not acceptable)
• No acute or chronic GI diseases (nausea, vomiting, GERD, diverticulitis, Crohn’s disease, hernia, IBS)
• No major organ diseases
• Not on insulin or SC medications more than one month
• Not currently on steroid or cancer treatment
• No smoking or alcohol

This study will enroll approximately 6 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.

Poxel- Non-alcoholic fatty liver disease trial that is randomized, double-blind, placebo-controlled – HSC 20190148H/P20903
Principal Investigators: Dr. Ralph A. DeFronzo

Purpose: To assess the safety and efficacy of PXL770 after 12 weeks of treatment in patients with Type 2 diabetes.

Eligibility:

• Age ≥ 18 to ≤ 75 years
• BMI ≥ 25 - ≤ 50
• ALT > 20 in females, > 30 in males
• Type 2 diabetes
• EGFR ≥ 60

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: 30-35 kg/m^2; males or females
• Diagnosis of Type 2 diabetes, 5 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.

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 3-4 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.

Poxel- Non-alcoholic fatty liver disease trial that is randomized, double-blind, placebo-controlled – HSC 20190148H/P20903
Principal Investigators: Dr. Ralph A. DeFronzo

Purpose: To assess the safety and efficacy of PXL770 after 12 week treatment in patients without Type 2 diabetes.

Eligibility:

• Age ≥ 18 to ≤ 75 years
• BMI ≥ 25 - ≤ 50
• ALT > 20 in females, > 30 in males
• Without Type 2 diabetes
• EGFR ≥ 60

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