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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00927355 |
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Date of registration:
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24/06/2009 |
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Primary sponsor: |
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Public title:
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Effect of Thiazolidinediones on Human Bone
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Scientific title:
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Effects of Thiazolidinediones on Human Bone Marrow Stromal Cell Differentiation Capacity:In Vitro and In Vivo- A Pilot Study |
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Date of first enrolment:
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April 2009 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00927355 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
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Countries of recruitment
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United States
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Contacts
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Name:
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Natasha B Khazai, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Emory University |
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Key inclusion & exclusion criteria
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Inclusion Criteria: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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Adipocytes
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Adiponectin
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Bone Density
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Mesenchymal Stem Cells
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Osteoblast
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Osteocalcin
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Intervention(s)
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Drug: Pioglitazone or placebo
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Primary Outcome(s)
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adipocyte and osteoblast colony forming units cultured from bone marrow stem cells
[Time Frame: 6 months]
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Secondary Outcome(s)
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Bone mineral density
[Time Frame: 6 months]
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CTX, P1NP, osteocalcin, leptin and adiponectin.
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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