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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly NGT | Normoglycemic subjects 65-80 years old | ||
| Middle-age NGT | Middle-age normoglycemic subjects 35 to 50 years old. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration | measured in fasting serum sample by ELISA kit | within 1 month from screening visit |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult normoglycemic subjects
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| Name | Affiliation | Role |
|---|---|---|
| Bruno Geloneze, MD, PhD | LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LIMED (Laboratory of Investigation of Metabolism and Diabetes)/GASTROCENTRO/Univeristy of Campinas (UNICAMP) | Campinas | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24854384 | Derived | 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. |
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Cross-sectional study conducted with 24 non-obese patients with normal glucose tolerance. Two groups formed: middle-aged (n=12) and aged(n=12). They were healthy and had no significant illness. None were taking drugs that affect insulin sensitivity/secretion or incretin hormones.
The recruitment process took place at the Laboratory of Investigation on Metabolism and Diabetes - LIMED, located at the Medical School of the State University of Campinas (UNICAMP).
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| ID | Title | Description |
|---|---|---|
| FG000 | Elderly Normal Glucose Tolerance (NGT) | Normoglycemic subjects 65-80 years old |
| FG001 | Middle-age Normal Glucose Tolerance (NGT) | Middle-age normoglycemic subjects 35 to 50 years old. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elderly Normal Glucose Tolerance (NGT) | Normoglycemic subjects 65-80 years old |
| BG001 | Middle-age Normal Glucose Tolerance (NGT) | Middle-age normoglycemic subjects 35 to 50 years old. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | minimum number required to find a significant difference between groups considering the intra-subject variation | Posted | Sep 2011 | Mean | Standard Deviation | units on a scale | within 1 month from screening visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elderly Normal Glucose Tolerance (NGT) | Normoglycemic subjects 65-80 years old |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bruno Geloneze | Laboratory of Investigation on Metabolism and Diabetes - LIMED / State University of Campinas - Brazil | +55 19 35218589 | bgeloneze@terra.com.br |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Sera and plasma
| 1 month from screening visit |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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 | Posted | Mean | Standard Deviation | mg*[kg(FFM)^-1]*min*10 | within 1 month from screening visit |
|
|
|
|
| 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 | Posted | Sep 2011 | Mean | Standard Deviation | (μmol∙kg-1min-1) | within 1 month from screening visit |
|
|
|
|
| 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. | Posted | Mean | Standard Error | (μmol∙kg-1.min-1) | within 1 month from screening visit |
|
|
|
|
| Secondary | Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration | measured in fasting serum sample by ELISA kit | Posted | Mean | Standard Deviation | pg/ml | within 1 month from screening visit |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | pg/ml/min | 1 month from screening visit |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Middle-age Normal Glucose Tolerance (NGT) | Middle-age normoglycemic subjects 35 to 50 years old. | 0 | 12 | 0 | 12 |
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |