Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance
Primary Purpose
Impaired Glucose Tolerance
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Rosiglitazone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Impaired Glucose Tolerance focused on measuring IGT
Eligibility Criteria
Inclusion Criteria:
- Subjects must sign the informed consent to participate in the study.
- Male or female adults ages 25-75 years.
- Female subjects must be postmenopausal (i.e., > 6 months without menstrual period), surgically sterile, or using effective barrier contraceptive measures (Intra-Uterine Device (IUD), diaphragm with spermicide or condom with spermicide).
- Women of childbearing potential must use effective barrier contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
- Female subjects of childbearing potential must have a negative urine pregnancy test.
- Subjects must have an FPG < 126 mg/dL at Screening 1 AND Screening 2, a C-peptide > 2.0 ng/mL and a HbA1c <6.5%.
- Subjects must have a Body Mass Index 25-40 (must be < 300 lbs).
- Subjects must have a 2 hour post-prandial glucose 140-199 mg/dL at Screening 1 AND Screening 2. If the 2 hour post-prandial glucose result is 130-139 mg/dL at Screening 2, subjects will be allowed to repeat the OGTT.
Exclusion Criteria:
- Women who are lactating, pregnant, or planning to become pregnant during the study will be excluded.
- Women using hormone contraception or on hormone replacement therapy will be excluded.
- Subjects with any clinically significant abnormality identified on the Screening physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study will also be excluded.
- Use of any other investigational agents or participation in any other investigational studies during the study period will not be allowed.
- Patients will also be excluded if there is a presence of clinically significant hepatic disease or patient with LFT levels > 2 times the upper limit of normal laboratory range
- Subjects with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones
- Subjects with any contraindications to rosiglitazone
- Presence of unstable or severe (New York Heart Association-NYHA class 3 or 4) angina, including angina requiring continual nitrate treatment for symptomatic relief, or coronary insufficiency
- Subjects with HYHA class 3 or 4 of congestive heart failure requiring drug therapy; systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
- History of cancer (except non-melanomatous skin carcinoma)
- Active alcohol or drug abuse within the last 6 months
- Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
- Subjects who are unable to understand dosing directions or swallow study medications
- Subjects who are currently smoking
- Subjects unable to adhere to protocol requirements.
- Persons with angina or any other cardiac or pulmonary symptoms that would potentially limit exercise performance will be excluded.
- Persons taking prescription or over-the-counter weight loss medications or persons on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 30 days of screening will also be excluded.
Sites / Locations
- South Federal Family PracticeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Rosiglitazone
Placebo
Outcomes
Primary Outcome Measures
Effect of rosiglitazone vs. placebo on exercise tolerance
Secondary Outcome Measures
Full Information
NCT ID
NCT00733174
First Posted
August 8, 2008
Last Updated
August 11, 2008
Sponsor
Denver Research Institute
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT00733174
Brief Title
Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance
Official Title
Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2004 (undefined)
Primary Completion Date
January 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Denver Research Institute
Collaborators
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Subjects with impaired glucose tolerance will be randomized to either rosiglitazone or placebo for a 18 month period. The study will look at baseline, 12 month and 18 month data for exercise tolerance, coronary artery calcification and diabetes indicators.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
IGT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rosiglitazone
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect of rosiglitazone vs. placebo on exercise tolerance
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must sign the informed consent to participate in the study.
Male or female adults ages 25-75 years.
Female subjects must be postmenopausal (i.e., > 6 months without menstrual period), surgically sterile, or using effective barrier contraceptive measures (Intra-Uterine Device (IUD), diaphragm with spermicide or condom with spermicide).
Women of childbearing potential must use effective barrier contraceptive measures for at least 1 month prior to visit 1, and should continue to use the same contraceptive method during the study and for 30 days after discontinuing study medication.
Female subjects of childbearing potential must have a negative urine pregnancy test.
Subjects must have an FPG < 126 mg/dL at Screening 1 AND Screening 2, a C-peptide > 2.0 ng/mL and a HbA1c <6.5%.
Subjects must have a Body Mass Index 25-40 (must be < 300 lbs).
Subjects must have a 2 hour post-prandial glucose 140-199 mg/dL at Screening 1 AND Screening 2. If the 2 hour post-prandial glucose result is 130-139 mg/dL at Screening 2, subjects will be allowed to repeat the OGTT.
Exclusion Criteria:
Women who are lactating, pregnant, or planning to become pregnant during the study will be excluded.
Women using hormone contraception or on hormone replacement therapy will be excluded.
Subjects with any clinically significant abnormality identified on the Screening physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study will also be excluded.
Use of any other investigational agents or participation in any other investigational studies during the study period will not be allowed.
Patients will also be excluded if there is a presence of clinically significant hepatic disease or patient with LFT levels > 2 times the upper limit of normal laboratory range
Subjects with a documented history of significant hypersensitivity (e.g., difficulty swallowing, difficulty breathing, tachycardia or skin reaction) to thiazolidinediones
Subjects with any contraindications to rosiglitazone
Presence of unstable or severe (New York Heart Association-NYHA class 3 or 4) angina, including angina requiring continual nitrate treatment for symptomatic relief, or coronary insufficiency
Subjects with HYHA class 3 or 4 of congestive heart failure requiring drug therapy; systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg
History of cancer (except non-melanomatous skin carcinoma)
Active alcohol or drug abuse within the last 6 months
Subjects with chronic diseases requiring periodic or intermittent treatment with oral or intravenous corticosteroids
Subjects who are unable to understand dosing directions or swallow study medications
Subjects who are currently smoking
Subjects unable to adhere to protocol requirements.
Persons with angina or any other cardiac or pulmonary symptoms that would potentially limit exercise performance will be excluded.
Persons taking prescription or over-the-counter weight loss medications or persons on a weight loss program with ongoing weight loss, or starting an intensive exercise program within 30 days of screening will also be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Mitchell, BSN, RN
Phone
303-399-8020
Ext
2059
Email
stacey.mitchell@va.gov
Facility Information:
Facility Name
South Federal Family Practice
City
Denver
State/Province
Colorado
ZIP/Postal Code
80219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annette Grissett, MA
Phone
303-934-2202
Email
annetteg@roydurbin.com
First Name & Middle Initial & Last Name & Degree
Stacey Mitchell, BSN, RN
Phone
303-399-8020
Ext
2059
Email
stacey.mitchell@va.gov
12. IPD Sharing Statement
Learn more about this trial
Rosiglitazone Therapy In The Prevention Of Coronary Artery Disease In Patients With Impaired Glucose Tolerance
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