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

  • STATUS
    Recruiting
  • End date
    Jul 25, 2024
  • participants needed
    700
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 25 January 2021
fasting
impaired glucose tolerance
metformin
pioglitazone
dapagliflozin
prediabetic state
saxagliptin

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 function, insulin sensitivity, and glucose tolerance status in individuals with isolated impaired fasting glucose (IFG): (i) treatment with the renal SGLT2 inhibitor, dapagliflozin; (ii) treatment with the DPP4 inhibitor, saxagliptin; (iii) treatment with the thiazolidinedione, pioglitazone; (iv) treatment with the biguanide, metformin.
  3. To examine the effect of the following pharmacologic interventions on beta cell function, insulin sensitivity, and glucose tolerance status in individuals with combined impaired glucose tolerance (IGT) plus impaired fasting glucose (IFG): i) treatment with the renal SGLT2 inhibitor, dapagliflozin; (ii) treatment with the DPP4 inhibitor, saxagliptin; (iii) treatment with the thiazolidinedione, pioglitazone; (iv) treatment with the biguanide, metformin.

Details
Condition NIDDM, Prediabetes, Glucose Intolerance, Diabetes Mellitus, Type 2, Impaired Fasting Glucose (IFG), Impaired Fasting Glucose, Diabetes Mellitus Type 2, impaired glucose tolerance, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Metformin, Saxagliptin, Dapagliflozin, pioglitazone
Clinical Study IdentifierNCT02969798
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have any of these conditions: Glucose Intolerance or Diabetes Mellitus, Type 2 or Impaired Fasting Glucose or Impaired Fasting Glucose (IFG) or Diabetes Mellitus Type 2 or NIDDM?
Do you have any of these conditions: type ii diabetes or Glucose Intolerance or noninsulin-dependent diabetes mellitus or Prediabetes or Impaired Fasting Glucose (IFG) or Diabetes Mellitu...?
NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects
Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening
FPG < 100 mg/dl and 2-h PG < 140 mg/dl
BMI = 24-40 kg/m2
Stable body weight (4lbs) over the preceding 3 months
Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
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

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
Subjects with a family history of diabetes in a first degree relative
BMI of less than 24 or greater than 40 kg/m2
Unstable body weight (change of greater than 4lbs over the preceding 3 months
Subjects participating in an excessively heavy exercise program
Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded
Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data
Pregnant subjects or subjects unwilling to use birth control during their study enrollment
Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening
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
Subjects with hematuria will be excluded
Subjects with evidence or prior history of heart failure will be excluded
Subjects with family history of pancreatic, bladder, and breast cancer will be excluded
Subjects with history of pancreatitis will be excluded
Subjects with eGFR < 60 5 ml/min.1.73m2 will be excluded
Subjects with elevated serum creatinine (>1.5 mg/dl males/1.4 mg/dl females) will be excluded
Subjects with a history of orthostatic hypotension (>15/10 mmHg) will be excluded
Subjects with liver enzymes (ALT, AST) >3-fold above upper normal limit will be excluded
Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded
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