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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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 or disease |
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Diabetes Mellitus, Type 2 Insulin Resistance |
Study Type : | Observational |
Actual Enrollment : | 24 participants |
Observational Model: | Case-Control |
Time Perspective: | Cross-Sectional |
Official Title: | The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly. |
Study Start Date : | June 2009 |
Actual Primary Completion Date : | September 2010 |
Actual Study Completion Date : | September 2010 |
Group/Cohort |
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Elderly NGT
Normoglycemic subjects 65-80 years old
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Middle-age NGT
Middle-age normoglycemic subjects 35 to 50 years old.
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- 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.
- 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.
Biospecimen Retention: Samples Without DNA

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Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843479
Brazil | |
LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP) | |
Campinas, SP, Brazil |
Principal Investigator: | Bruno Geloneze, MD, PhD | LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP) |
Responsible Party: | Bruno Geloneze, Dr. Bruno Geloneze, University of Campinas, Brazil |
ClinicalTrials.gov Identifier: | NCT00843479 |
Other Study ID Numbers: |
LIMED0006 |
First Posted: | February 13, 2009 Key Record Dates |
Results First Posted: | April 22, 2013 |
Last Update Posted: | April 22, 2013 |
Last Verified: | March 2013 |
diabetes mellitus, type 2 Insulin resistance Aging Incretins DPP-IV protein, human |
Glucagon-Like Peptide 1 Gastric Inhibitory Polypeptide insulin glucagon ghrelin |
Diabetes Mellitus Insulin Resistance Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperinsulinism |