Actos Now for Prevention of Diabetes (ACT NOW)
Condition: Impaired Glucose Tolerance; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Intolerance
Intervention: Pioglitazone; Placebo
Intervention description: Pioglitazone tablets - 45 mg/day; Placebo tablets similar to pioglitazone tablets - 1 tablet/day
Intervention MeSH terms: Pioglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 602.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Impaired Glucose Tolerance; Type 2 Diabetes; Prevention; Pioglitazone

Summary:

      The purpose of this study is to examine whether pioglitazone versus placebo can reduce the
      conversion rate of impaired glucose tolerance (IGT) to type 2 diabetes mellitus
    

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