The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly

Tracking Information
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; (submitted: March 7, 2013)	Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index [ Time Frame: within 1 month from screening visit ]Insulin sensitivity index calculated as HOMA-IR = (Glucose * Insulin) / 22.5, where glucose is mmol/L and insulin is mili-units (mU)/L. Higher values indicate lower insulin sensitivity.; Glucose Infusion Rate [ Time Frame: within 1 month from screening visit ]Whole-body insulin sensitivity, as estimated by the mean glucose infusion rate corrected for fat-free mass(FFM){mg*[kg(FFM)^-1]*min*10} at last 60 min of 180-min hyperglycemic clamp; Adaptive Beta-cell Insulin Production. The Product of Meal Tolerance Test-derived Insulinogenic Index (IGI) for Clamp-derived Insulin Sensitivity Index (ISI) in Normoglycemic Subjects After 65 Years Old in Comparison With Middle-age Normoglycemic Subjects [ Time Frame: within 1 month from screening visit ]Beta-cell function was determinated as the beta-cell secretion measured by meal tolerance test adjusted by insulin sensitivity assessed by the hyperglycemic clamp test:Insulinogenic Index/Insulin Sensitivity Index adjusted by free fat mass; Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects. [ Time Frame: within 1 month from screening visit ]Distinctive beta-cell function as measured by the disposition index - based on the acute insulin response from the arginine stimulation test versus glucose infusion rate adjusted by free fat mass from hyperglycemic clamp - in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects.
Original Primary Outcome Measures; (submitted: February 12, 2009)	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	Complete list of historical versions of study NCT00843479 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: March 7, 2013)	Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration [ Time Frame: within 1 month from screening visit ]measured in fasting serum sample by ELISA kit; GLP-1 Area Under the Curve (AUC) [ Time Frame: 1 month from screening visit ]Area under the curve of glucagon-like peptide (GLP-1) concentrations (measured by ELISA kit) from time 0 to 180 min during a standard meal tolerance test, calculated by the trapezoidal rule.
Original Secondary Outcome Measures; (submitted: February 12, 2009)	Distinctive whole-body insulin sensitivity, as estimated by hyperglycemic clamp in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects. [ Time Frame: within 1 month from screening visit ]; Distinctive beta-cell function (beta-cell secretion and sensitivity), as measured by hyperglycemic clamp in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects. [ Time Frame: within 1 month from screening visit ]; Distinctive acute insulin response as measured by arginine stimulation test in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects. [ Time Frame: within 1 month from screening visit ]; Distinctive DPP-IV activity as measured by spectrophotometer in normoglycemic subjects after sixty-five years old in comparison with middle-age normoglycemic subjects. [ Time Frame: within 1 month from screening visit ]
Current Other Outcome Measures	Not Provided
Original Other 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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case Control; Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA; Description: Sera and plasma
Sampling Method	Non-Probability Sample
Study Population	Adult normoglycemic subjects
Condition	Diabetes Mellitus, Type 2; Insulin Resistance
Intervention	Not Provided
Study Groups/Cohorts	Elderly NGT Normoglycemic subjects 65-80 years old; Middle-age NGT Middle-age normoglycemic subjects 35 to 50 years old.
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: February 12, 2009)	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: Stable weight (< 5% variation) within the last three months; Age: 35 to 50 years old for middle-age group, and 65 to 80 years old for elderly group.; BMI: 20 to 29.9 kg/m2; Normal glucose tolerance (NGT) for groups Elderly and Middle-age Exclusion Criteria: Use of estrogen, progestogen or systemic corticosteroids.; Hepatic cirrhosis, renal failure or any clinical condition with impaired insulin sensitivity; Smoking; Obesity; Uncontrolled systemic or debilitating diseases
Sex/Gender	Sexes Eligible for Study: All
Ages	35 Years to 80 Years (Adult, Senior)
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	Principal Investigator: Bruno Geloneze, MD, PhD LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
PRS Account	University of Campinas, Brazil
Verification Date	March 2013