Evaluate the Side Effects and Benefits of Rosiglitazone With or Without Diet and Exercise in Type II Diabetes Mellitus - NCT00737152-08901 (Clinical Trial 237317)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy237317.aspx
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| City: |
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New Brunswick |
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State:
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NJ |
| Zip Code: |
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08901 |
| Conditions: |
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Type II Diabetes Mellitus |
| Purpose: |
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Rationale: Rosiglitazone is an anti-diabetic agent used to lower the blood glucose level in
Type II Diabetes mellitus (non-insulin-dependent diabetes) patients with proper diet and
exercise. Rosiglitazone works by restoring proper response to insulin in the body.
Rosiglitazone acts primarily by increasing insulin sensitivity which improves glycemic
index. It is presumed that Rosiglitazone does not cause cardiovascular side effects if it
is given to Type II diabetes mellitus patients leading a healthy life style. Specifically,
controlling diet is done according to American Diabetic Association & American Heart
Association guidelines and also through doing aerobic exercises. Guideline for aerobic
exercise is given in the design of the study.
Exercise is helpful in controlling body weight which can lower the risk for heart disease.
Diabetes itself is one of the compounding factors for heart diseases. Exercise helps
lowering the LDL cholesterol and raising the HDL cholesterol which is required to prevent
heart diseases and achieve a better quality of life.
Purpose: The aim of this study is to prospectively assess and evaluate the cardiovascular
side effects and reduction of blood glucose levels in the Type II Diabetes mellitus patients
treated with Rosiglitazone, who either met, or failed to meet criteria for diet and
exercise.
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| Study summary: |
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Objectives:
Primary Objective:
To determine the relatedness of cardio toxicity as a side effect in subjects with DM II who
are treated with Rosiglitazone who either met, or failed to meet the criteria for diet and
exercise.
Hypothesis I: There will be no evidence of cardiovascular side effects in subjects who are
determined to have maintained proper diet and exercise "healthy lifestyle" throughout the
study.
Hypothesis II: There may be evidence of cardiovascular side effects in subjects who are
determined to neglect proper diet and exercise "unhealthy lifestyle" throughout the study.
Secondary Objective:
To determine the effectiveness of Rosiglitazone on the reduction of blood glucose levels in
subjects with DM II.
Hypothesis III: Rosiglitazone will be effective in reducing blood glucose levels as a
single agent.
Hypothesis IV: Rosiglitazone will be effective in reducing blood glucose in combination
with other anti- diabetic agents. |
| Criteria: |
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Inclusion Criteria:
1. Patients with Type II Diabetes Mellitus (non-insulin-dependent), not taking any
anti-diabetic agent.
2. Fasting blood glucose level below 250mg/dL
3. Age 30 to 60 years
4. Both genders
5. HbA1c of 6.0% to 13.0%, inclusive
6. Body mass index (BMI) below 40 kg/m2
7. Female subjects not pregnant, not lactating, post-menopausal, surgically sterile or
using effective contraceptive measures are included.
8. Provide signed Informed Consent
Exclusion Criteria:
1. Subject unable to give Informed Consent
2. Patients with Type I Diabetes Mellitus
a. History of ketoacidosis
3. Serum creatinine > 2.0 mg or above
4. Liver Function Test; Elevated liver enzymes: ALT/AST (2.5 times the upper limit of
the reference range), Bilirubin Testing - Accept three fold, A/G ratio - Accept two
fold
5. Hypercholesterolemia (more than 300mg)
6. Myocardial Infarction (MI) within 6 months
7. Severe or unstable angina
8. Elevated triglycerides >500 mg/dL
9. Abnormal EKG reading
10. Abnormal assessment in stress Echocardiography (ultrasound imaging)for Left
Ventricular ejection fraction for congestive heart failure
11. Anemia (Hb <11 g/dl for men or <10 g/dl for women)
12. Blood Dyscrasia, Decrease in Hematocrit - Accept two fold, Low WBC count - Accept one
fold, Decrease platelet count - Accept three fold
13. Macular edema/ macular degeneration
14. Patients who are taking insulin
15. Subjects with systolic blood pressure >170 mmHg or diastolic blood pressure >90 mmHg
16. Active participation in another trial
17. Subject physically unable to perform exercise due to neurologic or orthopedic
conditions.
18. Patients taking antipsychotic medications.
19. Subjects testing positive for the illicit drugs (cocaine, amphetamines, heroin)
20. Subjects who smoke tobacco products
21. Females who are lactating, pregnant, or planning to become pregnant
22. Signs and symptoms of Congestive heart failure (such as shortness of breath or
swelling in upper extremities)
23. History of severe edema or a medically serious fluid retention |
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| Study is available at: |
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Robertwood Johnson Hospital
New Brunswick, NJ 08901
United States |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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