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Lay Description

Research Design/Plan: After screening, each subject will receive 1 measurements of EGP with prime-continuous Infusion of 3-3H-glucose. After completing the EGP measurement each subject will receive a Double Tracer OGTT.

Methods: Visit 1: Screening. Medical history will be obtained, physical exam performed, and pregnancy test performed.

Visit 2: Endogenous Glucose Production Measurement: The rate of EGP will be measured with 3-3H-glucose.

Visit 3: Double Tracer OGTT

Category

  • Mens Health
  • Reproductive Health
  • Womens Health
IRB Number
20170582HU
NCT Number
NCT03331289
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Health Status: Type 2 Diabetes Mellitus according to ADA criteria (subjects must be in good general health as determined by physical exam, medical history, blood chemistry-CBC, TSH, T4, EKG and urinalysis)
  • BMI: 21-45kg/m
  • HbA1C>7.0% and <10.5%
  • Medication: Drug naïve and/or on a stable dose of metformin and/or sulfonylurea (more than 3 months)

Exclusion Criteria

  • Health Status: Type 1 Diabetics
  • Proliferative diabetic retinopathy
  • Plasma Creatinine greater than 1.4mg/dL in females or greater than 1.5mg/dL in males, or 24 hour urine albumin excretion greater than 300mg/dL
  • Medication: Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Ralph DeFronzo
(210) 567-6691
defronzo@uthscsa.edu

Regulatory Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Local Recruitment Point of Contact
Ralph DeFronzo
(210) 567-6691
defronzo@uthscsa.edu

Local Recruitment Point of Contact
Andrea Hansis-diarte
+1 (210) 617-5300
hansisdiarte@uthscsa.edu

Principal Investigator
Ralph DeFronzo