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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
  Purpose

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.


Condition
Diabetes Mellitus, Type 2
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly.

Resource links provided by NLM:


Further study details as provided by University of Campinas, Brazil:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

Sera and plasma


Enrollment: 24
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Elderly NGT
Normoglycemic subjects 65-80 years old
Middle-age NGT
Middle-age normoglycemic subjects 35 to 50 years old.

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Adult normoglycemic subjects

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843479

Locations
Brazil
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Campinas, SP, Brazil
Sponsors and Collaborators
University of Campinas, Brazil
Investigators
Principal Investigator: Bruno Geloneze, MD, PhD LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
  More Information

No publications provided by University of Campinas, Brazil

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bruno Geloneze, Dr. Bruno Geloneze, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00843479     History of Changes
Other Study ID Numbers: LIMED0006
Study First Received: February 12, 2009
Results First Received: October 4, 2011
Last Updated: March 7, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Campinas, Brazil:
diabetes mellitus, type 2
Insulin resistance
Aging
Incretins
DPP-IV protein, human
Glucagon-Like Peptide 1
Gastric Inhibitory Polypeptide
insulin
glucagon
ghrelin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on November 20, 2014