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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bruno Geloneze, University of Campinas, Brazil
ClinicalTrials.gov Identifier:
NCT00843479
First received: February 12, 2009
Last updated: March 7, 2013
Last verified: March 2013

February 12, 2009
March 7, 2013
June 2009
September 2010   (final data collection date for primary outcome measure)
  • Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index [ Time Frame: within 1 month from screening visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00843479 on ClinicalTrials.gov Archive Site
  • Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration [ Time Frame: within 1 month from screening visit ] [ Designated as safety issue: Yes ]
    measured in fasting serum sample by ELISA kit
  • GLP-1 Area Under the Curve (AUC) [ Time Frame: 1 month from screening visit ] [ Designated as safety issue: Yes ]
    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.
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly
The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly.

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Sera and plasma

Non-Probability Sample

Adult normoglycemic subjects

  • Diabetes Mellitus, Type 2
  • Insulin Resistance
Not Provided
  • Elderly NGT
    Normoglycemic subjects 65-80 years old
  • Middle-age NGT
    Middle-age normoglycemic subjects 35 to 50 years old.
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.
 
Completed
24
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
35 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00843479
LIMED0006
No
Bruno Geloneze, University of Campinas, Brazil
University of Campinas, Brazil
Not Provided
Principal Investigator: Bruno Geloneze, MD, PhD LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
University of Campinas, Brazil
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP