Trial Outcomes & Findings for The Aging Endocrine Pancreas: Characterization of the Entero-insular Axis Physiology in the Elderly (NCT NCT00843479)

NCT ID: NCT00843479

Last Updated: 2013-04-22

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

24 participants

Primary outcome timeframe

within 1 month from screening visit

Results posted on

2013-04-22

Participant Flow

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).

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.

Participant milestones

Participant milestones
Measure	Elderly Normal Glucose Tolerance (NGT) Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) Middle-age normoglycemic subjects 35 to 50 years old.
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Elderly Normal Glucose Tolerance (NGT) n=12 Participants Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) n=12 Participants Middle-age normoglycemic subjects 35 to 50 years old.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants 0 • n=5 Participants	0 Participants 0 • n=7 Participants	0 Participants 0 • n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants 0 • n=5 Participants	12 Participants 0 • n=7 Participants	12 Participants 0 • n=5 Participants
Age, Categorical >=65 years	12 Participants 0 • n=5 Participants	0 Participants 0 • n=7 Participants	12 Participants 0 • n=5 Participants
Age Continuous	64 years STANDARD_DEVIATION 2 • n=5 Participants	44 years STANDARD_DEVIATION 4 • n=7 Participants	54 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment Brazil	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: within 1 month from screening visit

Population: minimum number required to find a significant difference between groups considering the intra-subject variation

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.

Outcome measures

Outcome measures
Measure	Elderly Normal Glucose Tolerance (NGT) n=12 Participants Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) n=12 Participants Middle-age normoglycemic subjects 35 to 50 years old.
Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index	1.91 units on a scale Standard Deviation 1.0	0.84 units on a scale Standard Deviation 0.21

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Elderly Normal Glucose Tolerance (NGT) n=12 Participants Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) n=12 Participants Middle-age normoglycemic subjects 35 to 50 years old.
Glucose Infusion Rate	0.48 mg[kg(FFM)^-1]min*10 Standard Deviation 0.16	1.73 mg[kg(FFM)^-1]min*10 Standard Deviation 0.13

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Elderly Normal Glucose Tolerance (NGT) n=12 Participants Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) n=12 Participants Middle-age normoglycemic subjects 35 to 50 years old.
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	1.7 (μmol∙kg-1min-1) Standard Deviation 0.9	3.4 (μmol∙kg-1min-1) Standard Deviation 1.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Elderly Normal Glucose Tolerance (NGT) n=12 Participants Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) n=12 Participants Middle-age normoglycemic subjects 35 to 50 years old.
Distinctive Beta-cell Function From the Arginine Stimulation Test in Normoglycemic Subjects After Sixty-five Years Old in Comparison With Middle-age Normoglycemic Subjects.	328.5 (μmol∙kg-1.min-1) Standard Error 303.4	223.5 (μmol∙kg-1.min-1) Standard Error 174.9

SECONDARY outcome

Timeframe: within 1 month from screening visit

measured in fasting serum sample by ELISA kit

Outcome measures

Outcome measures
Measure	Elderly Normal Glucose Tolerance (NGT) n=12 Participants Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) n=12 Participants Middle-age normoglycemic subjects 35 to 50 years old.
Serum Dipeptidyl Peptidase IV (DPP-IV) Concentration	1466.6 pg/ml Standard Deviation 1088.8	1458.2 pg/ml Standard Deviation 1006.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Elderly Normal Glucose Tolerance (NGT) n=12 Participants Normoglycemic subjects 65-80 years old	Middle-age Normal Glucose Tolerance (NGT) n=12 Participants Middle-age normoglycemic subjects 35 to 50 years old.
GLP-1 Area Under the Curve (AUC)	1061.7 pg/ml/min Standard Deviation 354.4	1027.1 pg/ml/min Standard Deviation 164.9

Adverse Events

Elderly Normal Glucose Tolerance (NGT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Middle-age Normal Glucose Tolerance (NGT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bruno Geloneze

Laboratory of Investigation on Metabolism and Diabetes - LIMED / State University of Campinas - Brazil

Phone: +55 19 35218589

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place