The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843479
• Other study ID #: LIMED0006
• Status: Completed
• Phase: N/A
• First received: February 12, 2009
• Last updated: March 7, 2013
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: March 2013
• Source: University of Campinas, Brazil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Insulin Resistance

Locations

Country	Name	City	State
Brazil	LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)	Campinas	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index	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.	within 1 month from screening visit	No
Primary	Glucose Infusion Rate	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	within 1 month from screening visit	No
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	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	within 1 month from screening visit	Yes
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.	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.	within 1 month from screening visit	Yes
Secondary	Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration	measured in fasting serum sample by ELISA kit	within 1 month from screening visit	Yes
Secondary	GLP-1 Area Under the Curve (AUC)	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.	1 month from screening visit	Yes