Actos Now for Prevention of Diabetes (ACT NOW)
Recruitment status was Active, not recruiting
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Impaired Glucose Tolerance Type 2 Diabetes |
Drug: Pioglitazone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Actos Now for Prevention of Diabetes (ACT NOW) |
- Prevention of Type 2 Diabetes
- Improvement in glycemic control
- Change in insulin secretion
- Change in insulin sensitivity
- Improvement in cardiovascular risk factors
- Change in blood pressure
- Change in atherosclerosis
- Occurrence of cardiovascular morbidity and mortality
- Change in body composition
- Change in adipocytokines
- Change in plasma sex steroids
- Change in renal function
- Adverse events
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | May 2007 |
IGT is a prediabetic state. If IGT can be prevented from progressing to overt diabetes, the hyperglycemia-related complications of this devastating disease can be prevented. Subjects with IGT will be identified with an oral glucose tolerance test (OGTT). Eligible subjects also will have a measurement of first phase insulin secretion and insulin sensitivity using the frequently sampled intravenous glucose tolerance test (FSIVGTT) and carotid intimal media thickness using carotid ultrasound. Following these measurements subjects will be randomized to receive pioglitazone or placebo and they will return every 3 months for determination of fasting plasma glucose (FPG) concentration and interim medical history. Recruitment will take place over 15 months. From the time that the recruitment period ends, subjects will be followed for a total of 24 months on pioglitazone or placebo. The OGTT will be repeated at 15,27, and 39 months, or if the FPG is ≥ 126 mg/dl on the 3-month follow up visits. If the diagnosis of diabetes is established before month 39 or at month 39, the FSIVGTT and carotid ultrasound will be repeated. At 39 months, subjects will be washed out of pioglitazone or placebo and the OGTT, FSIVGTT, and carotid ultrasound will be repeated at month 45.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Arizona | |
| Carl T. Hayden VA Medical Center | |
| Phoenix, Arizona, United States, 85012 | |
| United States, California | |
| USC-Keck School of Medicine | |
| Los Angeles, California, United States, 90033 | |
| University of California San Diego-San Diego VA Medical Center | |
| San Diego, California, United States, 92161 | |
| United States, District of Columbia | |
| Georgetown University | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Louisiana | |
| Pennington Biomedical Research Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, New York | |
| SUNY Health Science Center | |
| Brooklyn, New York, United States, 11203 | |
| United States, Tennessee | |
| University of Tennessee | |
| Memphis, Tennessee, United States, 38163 | |
| United States, Texas | |
| Texas Diabetes Institute | |
| San Antonio, Texas, United States, 78207 | |
| Principal Investigator: | Ralph A. DeFronzo, M.D. | Texas Diabetes Institute |
More Information
Additional Information:
No publications provided by Texas Diabetes Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00220961 History of Changes |
| Other Study ID Numbers: | 02-062A |
| Study First Received: | September 14, 2005 |
| Last Updated: | May 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Texas Diabetes Institute:
|
Impaired Glucose Tolerance Type 2 Diabetes Prevention Pioglitazone |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Intolerance Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Hyperglycemia Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013