Actos Now for Prevention of Diabetes (ACT NOW)
Impaired Glucose Tolerance, Type 2 Diabetes
About this trial
This is an interventional prevention trial for Impaired Glucose Tolerance focused on measuring Impaired Glucose Tolerance, Type 2 Diabetes, Prevention, Pioglitazone
Eligibility Criteria
Inclusion Criteria: Men and women All ethnic groups 18 years of age and older Impaired glucose tolerance by glucose tolerance test (fasting glucose 95-125 mg/dl and 2 hr glucose of 140-199 mg/dl) At least one of the following: One or more components of the insulin resistance syndrome (HDL < 40 mg/dl in females and <35 mg/dl in males, fasting triglycerides > 150 mg/dl, blood pressure > 135/85 mmHg, BMI > 24 kg/m2, waist circumference > 102 cm in men and > 88 cm in women) One or more first degree relatives with type 2 diabetes History of gestational diabetes Polycystic ovarian disease Minority ethnic background (Mexican American, African American, Asian and Pacific Islanders, Native American) Exclusion Criteria: Type 2 diabetes Previously treated with thiazolidinediones (ever) or metformin (within one year) Previously treated with a sulfonylurea, a meglitinide, an alpha glucosidase inhibitor for more than a week within last year or within the 3 months prior to randomization Previously treated with insulin (other than during pregnancy) for more than one week within the last year or within the 3 months prior to randomization Cardiovascular disease Hospitalization for treatment of heart disease or stroke in past 6 months New York Heart Association Functional Class > 2 Left bundle branch block or third degree AV block Aortic stenosis SBP > 180 mmHg or DBP > 105 mmHg Renal disease Anemia Hepatitis GI diseases (pancreatitis, inflammatory bowel disease) Recent or significant abdominal surgery Advanced pulmonary disease Chronic infections Weight loss > 10% in past 6 months Pregnancy and childbearing Major psychiatric disorders Excessive alcohol intake Thiazide use > 25 mg per day Non-selective beta blockers Niacin Systemic glucocorticoids Weight loss or weight gain medication Thyroid disease-suboptimally treated Active endocrine diseases (Cushing's, acromegaly) Plasma triglycerides over 400 mg/dl (despite treatment) History bladder cancer Hematuria
Sites / Locations
- Carl T. Hayden VA Medical Center
- USC-Keck School of Medicine
- University of California San Diego-San Diego VA Medical Center
- Georgetown University
- Pennington Biomedical Research Center
- SUNY Health Science Center
- University of Tennessee
- Texas Diabetes Institute
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
Pioglitazone
Placebo tablet similar to pioglitazone tablet
Pioglitazone tablet similar to placebo tablet