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:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01135394
Eligibility Criteria:
Inclusion Criteria:
* Age 35-64
* BMI: ≥ 25 and ≤ 40
Exclusion Criteria:
* Pregnancy as determined by urine pregnancy test Breast-feeding, or planning to become pregnant during the study
* Physical dimensions exceeding the limits of any equipment used
* Stage III or greater congestive heart failure
* Symptomatic peripheral vascular disease
* Stroke
* Severe hypertension (\>170/100 mmHg)
* Anemia (Hgb and Hct \< normal reference range)
* Receiving treatment for thyroid, pituitary, kidney or liver disease (except controlled thyroid hormone replacement)
* History of diabetes (as told by doctor, or taking diabetic medications Fasting glucose value diagnostic for diabetes 2-h oral glucose tolerance test diagnostic for diabetes
* Rheumatoid arthritis
* History of wrist, hip or leg fracture after the age of 45
* History of kidney stones
* Medications that the investigator judges will make interpretation of the results difficult or increase the risk of participation (e.g. anticoagulants)
* Any disease or condition that the investigator judges will affect bone metabolism or make interpretation of the results difficult or increase the risk of participation (e.g. anemia, cardiac decompensation, intolerance to pioglitazone, lidocaine, or other agents used)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
64 Years
Study:
NCT01135394
Study Brief:
Protocol Section:
NCT01135394