RecruitingNot applicable

Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether two types of pre-diabetes have different causes and need different treatments to help prevent type 2 diabetes. It includes people with high blood sugar before eating or after a sugar test, plus people with normal blood sugar for comparison.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The listed rules are for the normal-blood-sugar comparison group. They will be matched to people with pre-diabetes by age, sex, ethnic background, and body size.
  • Be 18 to 65 years old.
  • Have blood sugar below 100 mg/dL before eating and below 140 mg/dL two hours after a sugar test.
  • Have a BMI of 24 to 40. BMI is a measure of weight compared with height.
  • Have no weight change greater than 4 pounds in the past 3 months.
  • Have no signs of major organ disease on exams, health history, or lab tests.
  • If able to become pregnant, have negative pregnancy tests at screening and treatment visits. Use an approved birth control method through follow-up, 7 to 14 days after the last dose.
  • Sign and date a form agreeing to join after learning about the study. Be willing and able to follow study visits, treatment, tests, and procedures.

Who can't join

  • Have serious or unstable illness, major organ disease, or another health, mental health, or lab problem that could make the study unsafe or affect its results.
  • Have a parent, sibling, or child with diabetes, or a family history of pancreatic, bladder, or breast cancer.
  • Have a BMI below 24 or above 40, a weight change over 4 pounds in 3 months, a very heavy exercise routine, or an eating and sleeping schedule other than daytime eating and nighttime sleeping.
  • Take medicines that affect blood sugar, except metformin or pioglitazone, or medicines that affect brain nerve signals. Have an allergy to pioglitazone, dapagliflozin, or saxagliptin.
  • Be pregnant, be unwilling to use birth control during the study, or have donated about 1 pint of blood within 8 weeks before screening.
  • Have blood in the urine or low kidney function: an eGFR below the study's stated cutoff of 60 ±5 mL/min/1.73 m². Also excluded are creatinine levels above 1.5 mg/dL in men or 1.4 mg/dL in women; this blood test checks kidney function.
  • Have current or past heart failure, or a history of a blood pressure drop when standing greater than 15/10 mmHg.
  • Have a history of pancreatitis, which is swelling of the pancreas, or liver blood tests called ALT or AST more than 3 times the upper normal limit.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

TX