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

NCT00843479 | Completed Results

• 1 other identifier: LIMED0006
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

Elderly NGT

Normoglycemic subjects 65-80 years old

Middle-age NGT

Middle-age normoglycemic subjects 35 to 50 years old.

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult normoglycemic subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

Campinas, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 24854384 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sera and plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Results Point of Contact

• Title: Dr. Bruno Geloneze
• Organization: Laboratory of Investigation on Metabolism and Diabetes - LIMED / State University of Campinas - Brazil

bgeloneze@terra.com.br

+55 19 35218589

Study Officials

• Bruno Geloneze, MD, PhD

  LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Bruno Geloneze

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 22, 2013
• Results First Posted: April 22, 2013

Record last verified: 2013-03

Locations

BR (1)