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Lay Description


Category

  • Diabetes
IRB Number
20210284HU
NCT Number
NCT05305287
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
Male/Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl).
  • Treated with diet, metformin, and/or sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;
  • age = 18-75 years;
  • BMI = 25-40 kg/m2;
  • HbA1c = 7-10%; stable body weight (±4 pounds) over the preceding 3-months;
  • not taking any medication known to affect glucose metabolism other than antidiabetic medications.
  • Evidence of moderate/severe fatty liver (steatosis; grade S2/S3 on FibroScan corresponding to ≥10% fat on MRI-PDFF) and no/minimal hepatic fibrosis (grade F0/F1 on FibroScan).

Exclusion Criteria

  • Alcohol consumption >14 units/week for women and >21 units/week for men.
  • Cirrhosis (fibrosis stage 4).
  • Type 1 diabetes and/or GAD positive subjects.
  • Subjects not drug naive or have been on metformin more than 3 months.
  • Presence of proliferative retinopathy.
  • Urine albumin excretion > 300 mg/day.
  • Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected/proven liver cancer and any other liver disease other than NAFLD.
  • History of NY Class III-IV heart failure

T2D with NASH

Inclusion Criteria:

  • Confirmed T2D based on OGTT (2 h glucose ≥200 mg/dl).
  • Treated with diet, metformin, and/or sulfonylurea and in good general health determined by medical history, physical exam, and routine blood chemistries;
  • age = 18-75 years;
  • BMI = 25-40 kg/m2;
  • HbA1c = 7-10%;
  • stable body weight (±4 pounds) over the preceding 3-months;
  • not taking any medication known to affect glucose metabolism other than antidiabetic medications.
  • Evidence of moderate/severe fatty liver (steatosis; grade S2/S3 on FibroScan corresponding to ≥10% liver fat on MRI-PDFF) and moderate/severe hepatic fibrosis (grade F2/F3 on FibroScan).

Exclusion Criteria:

  • Alcohol consumption >14 units/week for women and >21 units/week for men.
  • Cirrhosis (fibrosis stage 4).
  • Type 1 diabetes and/or GAD positive subjects.
  • Subjects not drug naive or have been on metformin more than 3 months.
  • Presence of proliferative retinopathy.
  • Urine albumin excretion > 300 mg/day.
  • Evidence of other forms of chronic liver disease, including alcoholic liver disease, hepatitis B and C, primary biliary cholangitis, suspected/proven liver cancer and any other liver disease other than NAFLD.
  • History of NY Class III-IV heart failure

Study Design

Arm Groups

Study Contact


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

Luke Norton
(210) 567-0739
nortonl@uthscsa.edu

Luke Norton
(210) 567-0739
nortonl@uthscsa.edu

Principal Investigator
Luke Norton