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

  • STATUS
    Recruiting
  • End date
    Jul 17, 2024
  • participants needed
    700
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 7 October 2022
fasting
impaired glucose tolerance
metformin
pioglitazone
dapagliflozin
prediabetic state
saxagliptin
Accepts healthy volunteers

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 Diabetes Mellitus, Type 2, Impaired Glucose Tolerance (IGT), Impaired Fasting Glucose (IFG)
Treatment Metformin, Saxagliptin, Dapagliflozin, pioglitazone
Clinical Study IdentifierNCT02969798
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Evidence of a personally signed and dated informed consent document indicating
that the subject has been informed of all pertinent aspects of the study
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
Subjects participating in an excessively heavy exercise program
Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule
Unstable body weight (change of greater than ±4lbs over the preceding 3 months
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 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 eGFR < 60 ±5 ml/min.1.73m2 will be excluded
Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note