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NCT Number: NCT00843479

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Campinas, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index

    Time frame: within 1 month from screening visit

    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.

  2. Glucose Infusion Rate

    Time frame: within 1 month from screening visit

    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

  3. 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

    Time frame: within 1 month from screening visit

    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

  4. Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.

    Time frame: within 1 month from screening visit

    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.

Secondary outcomes

  1. Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration

    Time frame: within 1 month from screening visit

    measured in fasting serum sample by ELISA kit

  2. GLP-1 Area Under the Curve (AUC)

    Time frame: 1 month from screening visit

    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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 13, 2009
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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