Status:
COMPLETED
Pharmacogenomics of Thiazolidinediones
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
35-64 years
Phase:
NA
Brief Summary
The purpose of this study is to determine predictors of response to pioglitazone, an anti-diabetic medication. The investigators know from randomized clinical trials that some 30% of patients do not r...
Detailed Description
In phase I, subjects who are eligible based on height and weight and general health information will sign informed consent. In phase II, subjects will be screened to ensure that they fit the inclusion...
Eligibility Criteria
Inclusion
- Age 35-64
- BMI: ≥ 25 and ≤ 40
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2018
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01135394
Start Date
March 1 2009
End Date
May 31 2018
Last Update
March 15 2024
Active Locations (1)
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1
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201