Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT) (NCT02969798) | Clinical Trial Compass
RecruitingNot Applicable
Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)
United States700 participantsStarted 2014-01-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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):
✓. 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
What they're measuring
1
Beta cell function
Timeframe: 24 months after treatment phase begins
2
Insulin sensitivity
Timeframe: 24 months after treatment phase begins
3
Glucose tolerance status
Timeframe: 24 months after treatment phase begins
Trial details
NCT IDNCT02969798
SponsorThe University of Texas Health Science Center at San Antonio
✕. 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