N/A
N=24
The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly
Diabetes Mellitus, Type 2 · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT00843479 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index — 1.91; 0.84 units on a scale — p=0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- University of Campinas, Brazil
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index |
1.91; 0.84 | 0.001 sig |
| PRIMARY Glucose Infusion Rate |
0.48; 1.73 | 0.001 sig |
| PRIMARY 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 |
1.7; 3.4 | 0.01 sig |
| PRIMARY Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects. |
328.5; 223.5 | >0.05 |
| SECONDARY Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration |
1466.6; 1458.2 | >0.05 |
| SECONDARY GLP-1 Area Under the Curve (AUC) |
1061.7; 1027.1 | >0.05 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00843479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.