Actively Recruiting
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-08-27
700
Participants Needed
1
Research Sites
704 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
A
American Diabetes Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects between the ages of 18 and 65 years, inclusive, at Screening
- Normal glucose tolerance subjects matched by age, gender, ethnicity, and BMI to IGT and IFG subjects
- Fasting plasma glucose less than 100 mg/dl and 2-hour plasma glucose less than 140 mg/dl
- Body mass index between 24 and 40 kg/m2
- Stable body weight (±4 lbs) over the previous 3 months
- No evidence of major organ system disease based on physical exam, history, and lab data
- Females of childbearing potential must have a negative pregnancy test and use approved contraception throughout the study
- Signed informed consent document
- Willingness and ability to comply with study visits, treatment, lab tests, and procedures
You will not qualify if you...
- Evidence or history within 3 months of unstable significant diseases such as hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or neurological disorders
- Family history of diabetes in a first-degree relative
- BMI less than 24 or greater than 40 kg/m2
- Unstable body weight (change greater than ±4 lbs in last 3 months)
- Participation in excessively heavy exercise programs
- Feeding or sleeping schedules different from daytime feeding and nighttime sleeping
- Use of medications affecting glucose metabolism (except metformin and/or pioglitazone) or brain neurosynaptic function
- Evidence of major organ system disease by exam, history, or labs
- Pregnancy or unwillingness to use birth control during study
- Blood donation of about 500 mL within 8 weeks prior to screening
- Severe acute or chronic medical or psychiatric conditions or lab abnormalities increasing risk or interfering with results
- Presence of hematuria
- History or evidence of heart failure
- Family history of pancreatic, bladder, or breast cancer
- History of pancreatitis
- Estimated glomerular filtration rate less than 60 ±5 ml/min/1.73m2
- Elevated serum creatinine above 1.5 mg/dl in males or 1.4 mg/dl in females
- History of orthostatic hypotension (greater than 15/10 mmHg)
- Liver enzymes (ALT, AST) more than 3 times the upper normal limit
- History of hypersensitivity to pioglitazone, dapagliflozin, or saxagliptin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
R
Ralph A DeFronzo, MD
CONTACT
M
Monica Palomo, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
13
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