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.

Sponsors

Lead Sponsor: University of Campinas, Brazil

Source University of Campinas, Brazil
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.

Overall Status Completed
Start Date June 2009
Completion Date September 2010
Primary Completion Date September 2010
Study Type Observational
Primary Outcome
Measure Time Frame
Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index within 1 month from screening visit
Glucose Infusion Rate within 1 month from screening visit
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 within 1 month from screening visit
Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects. within 1 month from screening visit
Secondary Outcome
Measure Time Frame
Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration within 1 month from screening visit
GLP-1 Area Under the Curve (AUC) 1 month from screening visit
Enrollment 24
Condition
Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 35 Years

Maximum Age: 80 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Bruno Geloneze, MD, PhD Principal Investigator LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Location
Facility: LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)
Location Countries

Brazil

Verification Date

March 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Campinas, Brazil

Investigator Full Name: Bruno Geloneze

Investigator Title: Dr. Bruno Geloneze

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Elderly NGT

Description: Normoglycemic subjects 65-80 years old

Label: Middle-age NGT

Description: Middle-age normoglycemic subjects 35 to 50 years old.

Study Design Info

Observational Model: Case Control

Time Perspective: Cross-Sectional

Source: ClinicalTrials.gov