The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance (Bedrest)
This study is currently recruiting participants.
Verified May 2013 by University of California, San Francisco
Sponsor:
University of California, San Francisco
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01412216
First received: August 5, 2011
Last updated: May 17, 2013
Last verified: May 2013
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 5, 2011 | ||||||||
| Last Updated Date | May 17, 2013 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Endothelial Function [ Time Frame: 5 days ] [ Designated as safety issue: No ] Flow-mediated, brachial artery vasodilation (FMD) |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01412216 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Insulin Resistance [ Time Frame: 5 days ] [ Designated as safety issue: No ] The homeostatic model assessment (HOMA) method used to quantify insulin resistance (HOMA-IR) |
||||||||
| Original Secondary Outcome Measures ICMJE |
Insulin Resistance [ Time Frame: 5 days ] [ Designated as safety issue: No ] HOMA-IR |
||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance | ||||||||
| Official Title ICMJE | The Effects of Sedentarism on Vascular Function, Inflammation, and Insulin Resistance | ||||||||
| Brief Summary | The purpose of this study are twofold:
|
||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
||||||||
| Condition ICMJE |
|
||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 16 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years to 50 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01412216 | ||||||||
| Other Study ID Numbers ICMJE | Sedentarism | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | University of California, San Francisco | ||||||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | University of California, San Francisco | ||||||||
| Verification Date | May 2013 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||