NCT02969798 Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
| NCT ID | NCT02969798 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 700 participants |
| Start Date | 2014-01-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 700 participants in total. It began in 2014-01-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose): * Oral contraceptive * Injectable progesterone * Subdermal implant * Spermicidal foam/gel/film/cream/suppository * Diaphragm with spermicide * Copper or hormonal containing IUD * Sterile male partner vasectomized \> 6 month pre-dosing. 7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 8. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures. Exclusion Criteria: 1. Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease. 2. Subjects with a family history of diabetes in a first degree relative 3. BMI of less than 24 or greater than 40 kg/m2 4. Unstable body weight (change of greater than ±4lbs over the preceding 3 months 5. Subjects participating in an excessively heavy exercise program 6. Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule 7. Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded. 8. Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data 9. Pregnant subjects or subjects unwilling to use birth control during their study enrollment 10. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening. 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study 12. Subjects with hematuria will be excluded. 13. Subjects with evidence or prior history of heart failure will be excluded 14. Subjects with family history of pancreatic, bladder, and breast cancer will be excluded. 15. Subjects with history of pancreatitis will be excluded. 16. Subjects with eGFR \< 60 ±5 ml/min.1.73m2 will be excluded. 17. Subjects with elevated serum creatinine (\>1.5 mg/dl males/1.4 mg/dl females) will be excluded. 18. Subjects with a history of orthostatic hypotension (\>15/10 mmHg) will be excluded. 19. Subjects with liver enzymes (ALT, AST) \>3-fold above upper normal limit will be excluded. 20. Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded.
Contact & Investigator
Ralph A DeFronzo, MD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT02969798 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02969798 currently recruiting?
Yes, NCT02969798 is actively recruiting participants. Contact the research team at defronzo@uthscsa.edu for enrollment information.
Where is the NCT02969798 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT02969798 clinical trial?
NCT02969798 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Ralph A DeFronzo, MD at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 700 participants.
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