Clinical trial NCT00843479: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Insulin Resistance
Keywords: diabetes mellitus, type 2
Insulin resistance
Aging
Incretins
DPP-IV protein, human
Glucagon-Like Peptide 1
Gastric Inhibitory Polypeptide
insulin
glucagon
ghrelin
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult normoglycemic subjects

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.


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

Primary outcomes:
measure: Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index
timeFrame: within 1 month from screening visit
measure: Glucose Infusion Rate
timeFrame: within 1 month from screening visit
measure: 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
timeFrame: within 1 month from screening visit
measure: Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.
timeFrame: within 1 month from screening visit
Secondary outcomes:
measure: Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration
timeFrame: within 1 month from screening visit
measure: GLP-1 Area Under the Curve (AUC)
timeFrame: 1 month from screening visit
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
state: SP
Study officials:
affiliation: LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
name: Bruno Geloneze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.