Type 1 Diabetes Mellitus Bone Mineral Density in Childhood and Adolescence
This study is currently recruiting participants.
Verified May 2013 by Creighton University
Sponsor:
Creighton University
Information provided by (Responsible Party):
Laura Armas, Creighton University
ClinicalTrials.gov Identifier:
NCT01605149
First received: May 22, 2012
Last updated: May 15, 2013
Last verified: May 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 22, 2012 | ||||||||
| Last Updated Date | May 15, 2013 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | June 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 NCT01605149 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 | Type 1 Diabetes Mellitus Bone Mineral Density in Childhood and Adolescence | ||||||||
| Official Title ICMJE | Type 1 DM Bone Mineral Density in Childhood and Adolescence | ||||||||
| Brief Summary | Type 1 Diabetes Mellitus is a disease that has an effect on bone mineral density. It is unclear how and when it effects the bone density. The investigators are studying the effects of diabetes on bone mass compared to children without diabetes. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Children and adolescents with Type 1 DM |
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| Condition ICMJE | Type 1 Diabetes Mellitus | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Case
Patients with Type 1 Diabetes Mellitus |
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01605149 | ||||||||
| Other Study ID Numbers ICMJE | 12-16425 | ||||||||
| 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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