Trial · Observational
CompletedPhase not statedResults postedRegistry dataThis trial does not test a peptide that PepBank tracks.
Brazil
1 trial · 1 completed · 1 with posted results
The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly
NCT00843479Jun 2009 to Sept 2010
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Other
Elderly NGT
Normoglycemic subjects 65-80 years old
Other
Middle-age NGT
Middle-age normoglycemic subjects 35 to 50 years old.
Outcomes the sponsor listed as primary.
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.
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
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
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.
Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration
Time frame · within 1 month from screening visit
measured in fasting serum sample by ELISA kit
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Elderly Normal Glucose Tolerance (NGT) | 1.91 | 1.0 |
| Middle-age Normal Glucose Tolerance (NGT) | 0.84 | 0.21 |
| Group | Value (mg*[kg(FFM)^-1]*min*10) | Spread |
|---|---|---|
| Elderly Normal Glucose Tolerance (NGT) | 0.48 | 0.16 |
| Middle-age Normal Glucose Tolerance (NGT) | 1.73 | 0.13 |
| Group | Value ((μmol∙kg-1min-1)) | Spread |
|---|---|---|
| Elderly Normal Glucose Tolerance (NGT) | 1.7 | 0.9 |
| Middle-age Normal Glucose Tolerance (NGT) | 3.4 | 1.3 |
| Group | Value ((μmol∙kg-1.min-1)) | Spread |
|---|---|---|
| Elderly NGT | 328.5 | 303.4 |
| Middle-age NGT | 223.5 | 174.9 |
| Group | Value (pg/ml) | Spread |
|---|---|---|
| Elderly Normal Glucose Tolerance (NGT) | 1466.6 | 1088.8 |
| Middle-age Normal Glucose Tolerance (NGT) | 1458.2 | 1006.9 |
| Group | Value (pg/ml/min) | Spread |
|---|---|---|
| Elderly Normal Glucose Tolerance (NGT) | 1061.7 | 354.4 |
| Middle-age Normal Glucose Tolerance (NGT) | 1027.1 | 164.9 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Elderly Normal Glucose Tolerance (NGT)Normoglycemic subjects 65-80 years old | – | 0 / 12 | 0 / 12 |
| Middle-age Normal Glucose Tolerance (NGT)Middle-age normoglycemic subjects 35 to 50 years old. | – | 0 / 12 | 0 / 12 |
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