Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls
This study is enrolling participants by invitation only.
Sponsor:
Creighton University
Information provided by (Responsible Party):
Laura Armas, Creighton University
ClinicalTrials.gov Identifier:
NCT01592539
First received: May 3, 2012
Last updated: May 15, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | May 3, 2012 | ||||
| Last Updated Date | May 15, 2013 | ||||
| Start Date ICMJE | May 2012 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01592539 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls | ||||
| Official Title ICMJE | Skin Blood Flow in Patients With Type 1 Diabetes Mellitus Compared to Normal Controls | ||||
| Brief Summary | The effects of high serum glucose on bone could be direct or could be indirect through its effects on the microvasculature. Previous studies by Rendell et al and Brugler et al have found significant differences in skin blood flow between diabetics and control. The investigators are proposing that blood flow measurements of the skin may be correlated with bone remodeling rates in iliac bone biopsies. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients with Type 1 DM |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 60 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 19 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01592539 | ||||
| Other Study ID Numbers ICMJE | Creighton11 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Laura Armas, Creighton University | ||||
| Study Sponsor ICMJE | Creighton University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Creighton University | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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