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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT00580957
Eligibility Criteria:
Inclusion Criteria:
* For lean subjects:
* 21 subjects aged 18-60 yr.
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
* Body mass index \< 25Kg/m\^2 .
* Female volunteers of childbearing potential will undergo HCG pregnancy test at screening and again on the study day.
* For Obese subjects with metabolic syndrome:
* 21 subjects aged 18-60 yr.
* All potential volunteers will have routine blood test to screen for hepatic, renal, and hematological abnormalities.
* Body mass index \> 30Kg/m\^2.
* Participants will be enrolled if they met at least three of the following criteria for metabolic syndrome (Expert panel, Jama 2001):
1. Waist circumference \>102 cm in men and \>88 cm in women
2. High fasting blood sugar (\>110 mg%)
3. Triglyceride levels \>150 mg%
4. Low HDL cholesterol (\<40 mg% for men; \<50 mg% for women)
5. High blood pressure (systolic=130 and diastolic = 85 mmHg) • Female volunteers of childbearing potential will undergo serum HCG pregnancy test at screening and urine HCG pregnancy test again on the study day.
Exclusion Criteria:
* Pregnant females
* Subjects unable to give voluntary informed consent
* Subjects on anticoagulant drugs or anemic (anemia defined as Hcto less than 35%)
* Subjects with a recent medical illness documented by physicians's visit or detected during the screening visit.
* Subjects with a history of coronary heart disease.
* Subjects with known kidney or liver disease.
* Subjects with recent weight loss or consuming low carbohydrate diet.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00580957
Study Brief:
Protocol Section:
NCT00580957