Status:
COMPLETED
Effect of Diabetic Medications on Bone Metabolism
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Osteoporosis
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-55 years
Brief Summary
Subjects with diabetes and pre-diabetes are said to have increased bone loss when compared to the general population. Pioglitazone a thiazolidinedione, is a Food and Drug Administration (FDA) approved...
Detailed Description
The prevalence rate of diabetes among veterans is 16% in general and 27% at out medical center compared to 6.3% among United States population. Subjects with diabetes and prediabetes said to have incr...
Eligibility Criteria
Inclusion
- Age 30-55 years
- Gender: men and women
- Ethnicity: all ethnic groups
- 140 subjects with diabetes and no pioglitazone (recently started i.e. less than 3 months as well as those who have just initiated pioglitazone treatment)
- 140 control subjects (subjects with diabetes and not on pioglitazone) will be included
- The control subjects will be chosen to match age, sex, ethnicity and comparable smoking and alcohol history
- To avoid confusion factor of vitamin D and calcium intake, all the subjects will be given vitamin D and calcium supplements (USDA recommended doses)
Exclusion
- Patients who are unable or unwilling yo give informed consent
- Immobilized or bed bound subject
- Subjects wil known diseases associated with disordered bone metabolism such as chronic renal insufficiency, chronic steroid use, primary hyperparathyroidism, untreated subclinical or clinical hyperthyroidism and Paget's disease. To identify subjects with decreased Glomerular filtration rate (GFR) even if creatinine is normal will be excluded (at the proposed study site, routine bm includes calculated GFR from the chemistry lab)
- Patients on medications that will alter bone metabolism will be excluded. They are glucocorticoids, gonadal hormones (testosterone in men and estrogen in women).
- Subjects with known history of chronic pancreatitis, pancreatectomy or malabsorption syndromes to avoid confounding factors known to affect vitamin D metabolism and indirectly bone mineral metabolism.
- Female patients with perimenopause or menopause: history of hypogonadism (History of ovariectomy or postmenopausal women) to avoid bone turn over changes secondary to hypogonadism. Perimenopausal women identifies by screening FSH and LH and excluding women with elevated FSH be excluded to avoid perimenopausal effect on bone turnover (women over 35 will still have a screening gonadal hormonal evaluation).
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00467285
Start Date
October 1 2006
End Date
September 1 2009
Last Update
January 14 2015
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