Status:
COMPLETED
Effect of Thiazolidinediones on Human Bone
Lead Sponsor:
Emory University
Conditions:
Osteoblast
Adipocytes
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
We will prospectively study 2 groups of diabetic patients treated with pioglitazone or placebo for 26 weeks. Bone marrow aspirates will be obtained from these patients at baseline and after 26 weeks o...
Detailed Description
E2a. Screening: Prescreening of electronic medical records will be used as much as possible to reduce screen failure rates. Patients will undergo a full history (with special focus on inclusion and ex...
Eligibility Criteria
Inclusion
- Subjects with T2DM who are:
- naïve to insulin and TZD therapy
- On diet and lifestyle therapy along with submaximal metformin therapy
- with HbA1c between 7% and 8.0%
- between the ages of 18 and 80 years
- both genders
Exclusion
- Contraindications to TZD therapy including congestive heart failure class III or IV, and/or macular edema
- history of osteoporosis (T score \< -2.5 on DXA scanning) or osteoporotic fragility fracture
- treatment with glucocorticoids within 1 year of study enrollment
- treatment with bisphosphonates,calcitriol, raloxifene, Calcitonin, estrogen
- vitamin D insufficiency, defined as 25(OH)D levels \<30 ng/mL or
- hyperparathyroidism
- liver disease (LFTS \> 3x upper limits of normal)
- Kidney disease Cr\>1.4 in females and Cr\>1.5 in males
- smokers (active or within a month from stopping)
- alcohol or drug abuse/dependence
- hypogonadism in males
- mental conditions rendering the subject unable to understand the scope of the study
- female subjects who are pregnant or breast feeding
- chronic obstructive pulmonary disease
- obstructive sleep apnea.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00927355
Start Date
April 1 2009
End Date
July 1 2011
Last Update
March 29 2016
Active Locations (1)
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1
Grady Diabetes Clinic
Atlanta, Georgia, United States, 30303