Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT00308451
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of type 2 diabetes \> 12 months.
2. Post-prandial blood glucose (glucose \> 200 mg/dl) levels consistent with an ADA diagnosis of diabetes as confirmed during the screening visit.
3. Male and female between the ages of 18 and 65 years.
4. HbA1c \> 7.0%.
5. Use of treatment regimens including diet and exercise and/or drug therapy for diabetes are allowed. Drug therapy may include alpha-glucosidase inhibitors (e.g. acarbose, voglibose, miglitol) and oral hypoglycemic agents such as sulfonylureas and metformin and thiazolidinediones (TZDs). Insulin use is not allowable
6. No changes in medication dosage within 60 days prior to entering trial.
7. Subjects with a body mass index (BMI) \>25 and \< 35.
8. Fasting triglycerides \< 400. \[32\]
9. Willing to complete all study related requirements.
10. Subject will provide written consent to participate in the trial and this consent must be given voluntarily.
Exclusion Criteria:
1. Diagnosis of type I diabetes.
2. Hypoglycemic event requiring EMS intervention \< 12 months.
3. Diabetic Ketoacidosis (DKA) \< 12 months.
4. Subjects taking any supplement containing chromium within the previous 90 days prior toenrollment.
5. Creatinine \> 2.0 x ULN; AST or ALT \> 2.0 x ULN; Total Bilirubin \> 1.5 x ULN.
6. COPD, CHF, Angina, HTN, MI, or any other CVD requiring hospitalization within the previous 12 months.
7. History of cerebrovascular accident (CVA), pulmonary embolism (PE), or an unresolved deep vein thrombosis (DVT).
8. History of CABG, PTCA, or any other reperfusion therapy \< 12 months.
9. Uncontrolled high blood pressure (seated: systolic \> 160 mmHg or diastolic \> 90 mmHg)
10. History of any serious immunosuppressive disorder or undergoing current immunosuppressive therapy.
11. Female subjects who are pregnant or nursing, or are planning on becoming pregnant during the study. No hormone replacement therapy for post-menopausal subjects.
12. Hepatic disease, impaired thyroid, or impaired renal function, or other diseases known to affect glucose or lipid metabolism. TSH must be within range of normality to enter trial.
13. Diagnosed or self-reported alcoholism or substance-abuse problems
14. Any psychiatric or mental health issue that would prevent the subject from completing the study
15. Any illness or complication factor that, in the opinion of the investigator, would jeopardize the subject's health or well being by participating in the study or would interfere with the subject successfully completing the study.
16. Current participation in any other clinical research trial for any product or device, or participation in said clinical trials within 30 days prior to enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00308451
Study Brief:
Protocol Section:
NCT00308451