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Trial record 71 of 1011 for:    Area Under Curve AND insulin

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

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ClinicalTrials.gov Identifier: NCT00843479
Recruitment Status : Completed
First Posted : February 13, 2009
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Information provided by (Responsible Party):
Bruno Geloneze, University of Campinas, Brazil

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Cross-Sectional
Conditions Diabetes Mellitus, Type 2
Insulin Resistance
Enrollment 24
Recruitment Details 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).
Pre-assignment Details 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.
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Hide Arm/Group Description Normoglycemic subjects 65-80 years old Middle-age normoglycemic subjects 35 to 50 years old.
Period Title: Overall Study
Started 12 12
Completed 12 12
Not Completed 0 0
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT) Total
Hide Arm/Group Description Normoglycemic subjects 65-80 years old Middle-age normoglycemic subjects 35 to 50 years old. Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
12
 100.0%
12
  50.0%
>=65 years
12
 100.0%
0
   0.0%
12
  50.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
64  (2) 44  (4) 54  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
9
  75.0%
11
  91.7%
20
  83.3%
Male
3
  25.0%
1
   8.3%
4
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 12 participants 12 participants 24 participants
12 12 24
1.Primary Outcome
Title Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index
Hide Description 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.
Time Frame within 1 month from screening visit
Hide Outcome Measure Data
Hide Analysis Population Description
minimum number required to find a significant difference between groups considering the intra-subject variation
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Hide Arm/Group Description:
Normoglycemic subjects 65-80 years old
Middle-age normoglycemic subjects 35 to 50 years old.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.91  (1.0) 0.84  (0.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elderly Normal Glucose Tolerance (NGT), Middle-age Normal Glucose Tolerance (NGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.07
Estimation Comments [Not Specified]
2.Primary Outcome
Title Glucose Infusion Rate
Hide Description 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
Time Frame within 1 month from screening visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Hide Arm/Group Description:
Normoglycemic subjects 65-80 years old
Middle-age normoglycemic subjects 35 to 50 years old.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mg*[kg(FFM)^-1]*min*10
0.48  (0.16) 1.73  (0.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elderly Normal Glucose Tolerance (NGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.25
Estimation Comments [Not Specified]
3.Primary Outcome
Title 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
Hide Description 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
Time Frame within 1 month from screening visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Hide Arm/Group Description:
Normoglycemic subjects 65-80 years old
Middle-age normoglycemic subjects 35 to 50 years old.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: (μmol∙kg-1min-1)
1.7  (0.9) 3.4  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elderly Normal Glucose Tolerance (NGT), Middle-age Normal Glucose Tolerance (NGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Primary Outcome
Title Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.
Hide Description 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.
Time Frame within 1 month from screening visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Elderly NGT Middle-age NGT
Hide Arm/Group Description:
Normoglycemic subjects 65-80 years old
Middle-age normoglycemic subjects 35 to 50 years old
Overall Number of Participants Analyzed 12 12
Mean (Standard Error)
Unit of Measure: (μmol∙kg-1.min-1)
328.5  (303.4) 223.5  (174.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elderly NGT, Middle-age NGT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration
Hide Description measured in fasting serum sample by ELISA kit
Time Frame within 1 month from screening visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Hide Arm/Group Description:
Normoglycemic subjects 65-80 years old
Middle-age normoglycemic subjects 35 to 50 years old.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: pg/ml
1466.6  (1088.8) 1458.2  (1006.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elderly Normal Glucose Tolerance (NGT), Middle-age Normal Glucose Tolerance (NGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title GLP-1 Area Under the Curve (AUC)
Hide Description 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.
Time Frame 1 month from screening visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Hide Arm/Group Description:
Normoglycemic subjects 65-80 years old
Middle-age normoglycemic subjects 35 to 50 years old.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: pg/ml/min
1061.7  (354.4) 1027.1  (164.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Elderly Normal Glucose Tolerance (NGT), Middle-age Normal Glucose Tolerance (NGT)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Hide Arm/Group Description Normoglycemic subjects 65-80 years old Middle-age normoglycemic subjects 35 to 50 years old.
All-Cause Mortality
Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Elderly Normal Glucose Tolerance (NGT) Middle-age Normal Glucose Tolerance (NGT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Bruno Geloneze
Organization: Laboratory of Investigation on Metabolism and Diabetes - LIMED / State University of Campinas - Brazil
Phone: +55 19 35218589
Responsible Party: Bruno Geloneze, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT00843479     History of Changes
Other Study ID Numbers: LIMED0006
First Submitted: February 12, 2009
First Posted: February 13, 2009
Results First Submitted: October 4, 2011
Results First Posted: April 22, 2013
Last Update Posted: April 22, 2013