Pharmacogenomics of Thiazolidinediones

• Status: Completed
• Trial end date: 2018-05-31
• Target enrollment: 0
• Participant gender: All

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 respond to this type of medication. There is presently no way to identify this group of patients leading to unnecessary drug exposure and medication costs.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: 2,4-thiazolidinedione; Pioglitazone

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)