Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
The University of Texas Health Science Center at San Antonio
Summary
HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.
Description
SPECIFIC AIMS: 1. To examine the effect of the following pharmacologic interventions on beta cell function, insulin sensitivity, and glucose tolerance status in individuals with isolated impaired glucose tolerance (IGT): (i) treatment with the renal Sodium-glucose co-transporter 2 (SGLT2) inhibitor inhibitor, dapagliflozin; (ii) treatment with the inhibitors of dipeptidyl peptidase 4, also DPP4, saxagliptin ; (iii) treatment with the thiazolidinedione, pioglitazone; (iv) treatment with the biguanide, metformin. 2. To examine the effect of the following pharmacologic interventions on beta cell…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects 1. Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening. 2. FPG \< 100 mg/dl and 2-h PG \< 140 mg/dl 3. BMI = 24-40 kg/m2; 4. Stable body weight (±4lbs) over the preceding 3 months 5. Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data 6. Females of childbearing potential with a negative pregnancy test at Screening and Treatment visi…
Interventions
- DrugDapagliflozin
10mg/day
- DrugSaxagliptin
5mg/day
- DrugPioglitazone
the dose will increase from 15 mg/day to 30 mg/day at month two
- DrugMetformin
starting at 1000 mg/day and increased to 2000 mg/day at month 2.
Location
- The University of Texas Health Science Center at San AntonioSan Antonio, Texas