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Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow up (INFO)

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ClinicalTrials.gov Identifier: NCT01412554
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Tonje Amb Aksnes, Oslo University Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Conditions Diabetes Mellitus
Hypertension
Ischemic Heart Disease
Stroke
Enrollment 103
Recruitment Details

During 1991-96 men from the military enlistments were examined at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål, using hyperinsulinaemic isoglycaemic glucose clamp technique to assess insulin sensitivity.

They were re-invited to participate in the presented study during 2012-13.

Pre-assignment Details 103 consented to participation.
Arm/Group Title Longitudinal Insulin Sensitivity
Hide Arm/Group Description The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
Period Title: Overall Study
Started 103 [1]
Completed 103
Not Completed 0
[1]
103 persons re-examined in 2012-13 out of 158 persons originally examined in 1991-96.
Arm/Group Title Longitudinal Insulin Sensitivity
Hide Arm/Group Description The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
Overall Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
40  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
0
   0.0%
Male
103
 100.0%
1.Primary Outcome
Title Exploring Insulin Sensitivity After 10-20 Years of Follow-up
Hide Description The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.
Time Frame One-day visit and the analyses will be done when all patients are examined in the period 2012-2013
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Longitudinal Insulin Sensitivity
Hide Arm/Group Description:
The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: mg/kg/min
7  (2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Longitudinal Insulin Sensitivity
Comments Only an observational follow-up study
Type of Statistical Test Other
Comments Only descriptive statistics
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Spearman
Comments The degree of tracking was assessed by Spearman’s rank or Pearson’s correlation coefficient
Other Statistical Analysis The degree of tracking was assessed by Spearman’s rank or Pearson’s correlation coefficient
2.Primary Outcome
Title Exploring Insulin Sensitivity After 10-20 Years of Follow-up
Hide Description The primary outcome is insulin sensitivity measured as the glucose disposal rate (GDR) (mg/kg/min), calculated from the average glucose infusion rate during the last 20 minutes of a 120 minutes hyperinsulinaemic isoglycaemic glucose clamp.
Time Frame 20 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Sympathoadrenal Activity During Rest and Stress Tests
Hide Description A mental arithmetic stress test will be announced and performed immediately after the glucose clamp, to assess the effects of increased adrenaline and noradrenaline when hepatic glucose production is suppressed by hyperinsulinaemia. Blood pressure, heart rate and catecholamine blood-levels are measured at pre-defined intervals.
Time Frame One-day visit and analyses will be done during 2012-2013
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Echocardiography
Hide Description Transthoracic echocardiography will be performed using a VIVID E9 (or VIVID 7) echocardiographic scanner (GE Vingmed, Horten) with 1,7-MHz probe in second harmonic mode and optimal gain and contrast.Left ventricular (LV) internal dimension, intraventricular septal thickness and LV posterior wall thickness will be measured as well as epicardial adipose tissue. We will also evaluate biplane Simpson ejection fraction and valvular incompetence
Time Frame One-day visit, final analyses 2012-2013
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Ultrasound Abdomen
Hide Description Ultrasound quantification of abdominal adipose tissue
Time Frame One-day visit. Final analyses of the whole cohort during 2012-2013
Outcome Measure Data Not Reported
Time Frame 1 month
Adverse Event Reporting Description No adverse evnts
 
Arm/Group Title Longitudinal Insulin Sensitivity
Hide Arm/Group Description The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
All-Cause Mortality
Longitudinal Insulin Sensitivity
Affected / at Risk (%)
Total   0/103 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Longitudinal Insulin Sensitivity
Affected / at Risk (%)
Total   0/103 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Longitudinal Insulin Sensitivity
Affected / at Risk (%)
Total   0/103 (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
Layout table for Results Point of Contact information
Name/Title: MD PhD Tonje Amb Aksnes
Organization: Oslo University Hospital Ullevål, Norway
Phone: +22119101 ext 47
EMail: tonjeaksnes@hotmail.com
Layout table for additonal information
Responsible Party: Tonje Amb Aksnes, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01412554     History of Changes
Other Study ID Numbers: 2010/3339
First Submitted: July 22, 2011
First Posted: August 9, 2011
Results First Submitted: September 20, 2017
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019