Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440375
Status:
COMPLETED
Last Update Posted:
2007-02-27
First Post:
2007-02-26
Brief Title:
Effects of Rosiglitazone on Bone in Postmenopausal Diabetic Women
Sponsor:
Baskent University
Organization:
Baskent University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of rosiglitazone on bone metabolism and to assess the association between the changes in bone turnover parameters and plasma cytokine levels in postmenopausal diabetic women
Detailed Description:
Fifty-six obese drug naive patients with type 2 diabetes mellitus were enrolled and completed the study Twenty-six healthy subjects matched for age and body mass index BMI served as nondiabetic controls All subjects were postmenopausal women with last menses at least 2 years After the baseline measurements all subjects were instructed to follow a weight-maintaining diet based on ADA recommendations and were also encouraged to walk or to jog at least 30 min daily Subsequently 28 of the diabetic subjects were randomly assigned to receive rosiglitazone 4 mgday Twenty-eight of diabetic subjects were on diet alone The randomization procedure was based on a random sequence
All subjects had a complete clinical examination anthropometric measurements and laboratory tests at baseline and at the end of the 12th week of the study Laboratory investigations included assessment of i glycemic control HbA1c fasting plasma glucose and insulin levels and homeostasis model assessment HOMA index 22 ii serum bsALP and active human osteocalcin concentration OCL as markers of bone formation iii urine deoxypyridinoline DPD as marker of bone resorption Other non-specific bone markers including serum total ALP activity urinary calcium Ca and phosphate PO4 concentrations were also measured Urine concentrations of DPD nmolL Ca and PO4 both in mmolL were corrected for their respective urine creatinine Cr concentrations in mmolL Urine DPDCr Urine CaCr and Urine PO4Cr respectively In addition fasting blood samples were analyzed for plasma cytokine levels including IL-1β IL-6 and TNF-α and for haptoglobin levels
All subjects had a complete clinical examination anthropometric measurements and laboratory tests at baseline and at the end of the 12th week of the study Laboratory investigations included assessment of i glycemic control HbA1c fasting plasma glucose and insulin levels and homeostasis model assessment HOMA index 22 ii serum bsALP and active human osteocalcin concentration OCL as markers of bone formation iii urine deoxypyridinoline DPD as marker of bone resorption Other non-specific bone markers including serum total ALP activity urinary calcium Ca and phosphate PO4 concentrations were also measured Urine concentrations of DPD nmolL Ca and PO4 both in mmolL were corrected for their respective urine creatinine Cr concentrations in mmolL Urine DPDCr Urine CaCr and Urine PO4Cr respectively In addition fasting blood samples were analyzed for plasma cytokine levels including IL-1β IL-6 and TNF-α and for haptoglobin levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None