The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly
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ClinicalTrials.gov Identifier: NCT00843479 |
Recruitment Status :
Completed
First Posted : February 13, 2009
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
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Tracking Information | ||||
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First Submitted Date | February 12, 2009 | |||
First Posted Date | February 13, 2009 | |||
Results First Submitted Date | October 4, 2011 | |||
Results First Posted Date | April 22, 2013 | |||
Last Update Posted Date | April 22, 2013 | |||
Study Start Date | June 2009 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
Distinctive curves of glucose, insulin, C peptide, glucagon, GLP-1, GIP and ghrelin during a meal tolerance test, in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects. [ Time Frame: within 1 month from screening visit ] | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly | |||
Official Title | The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly. | |||
Brief Summary | Like most endocrine axes, the entero-insular axis is expected to go through an age-related physiological deterioration, what might contribute to special features of the elderly onset type 2 diabetes in comparison to middle-age. Twenty four NGT volunteers will be evaluated by a meal tolerance test (MTT) for incretin hormone measurements, and by the hyperglycemic clamp followed by an arginine test for assessing the beta-cell function and the acute insulin response. Others parameters as body composition and basic biochemistry will be also evaluated at Laboratory of Investigation on Metabolism and Diabetes - LIMED / State university of Campinas, Brazil. The characterization of the glucagon-like peptide-1 (GLP-1) production, dipeptidyl peptidase IV (DPP-IV) activity and/or endocrine pancreas incretin-response at aging, might be an interesting evidence to reinforce an incretin-based therapeutic approach for elderly onset type 2 diabetes. |
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Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples Without DNA Description: Sera and plasma
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Sampling Method | Non-Probability Sample | |||
Study Population | Adult normoglycemic subjects | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Geloneze B, de Oliveira Mda S, Vasques AC, Novaes FS, Pareja JC, Tambascia MA. Impaired incretin secretion and pancreatic dysfunction with older age and diabetes. Metabolism. 2014 Jul;63(7):922-9. doi: 10.1016/j.metabol.2014.04.004. Epub 2014 Apr 12. | |||
* 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 | Completed | |||
Actual Enrollment |
24 | |||
Original Estimated Enrollment | Same as current | |||
Actual Study Completion Date | September 2010 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 35 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Brazil | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00843479 | |||
Other Study ID Numbers | LIMED0006 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bruno Geloneze, University of Campinas, Brazil | |||
Study Sponsor | University of Campinas, Brazil | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | University of Campinas, Brazil | |||
Verification Date | March 2013 |