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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

Brief Summary:
The purpose of this study is to identify risk factors for insulin resistance and to investigate the influence of insulin sensitivity on development of cardiovascular risk markers like blood pressure, heart rate, body build (weight, BMI, waist-hip ratio, skinfold thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20 years.

Condition or disease
Diabetes Mellitus Hypertension Ischemic Heart Disease Stroke

Detailed Description:

In 1988 Reaven described a syndrome designed "syndrome X" based on the clustering of resistance to insulin-stimulated glucose uptake, hyperinsulinaemia, hyperglycaemia, increased triglycerides, decreased high-density lipoprotein (HDL) cholesterol and high blood pressure and proposed insulin resistance as the common feature and the aetiology of the syndrome. Later obesity and the sympathetic nervous system have been proposed as pathogenic factors of the metabolic syndrome, and still major controversy exists regarding its precise aetiology and different definitions of metabolic syndrome are also discussed.

Insulin resistance is a growing epidemic concern in both industrialized and developing countries. It is one of the components of the metabolic syndrome, and plays an important role in the pathogenesis of type 2 diabetes. In view of the predicted increase in the number of diabetic patients during the coming decades, further information about risk factors and pathophysiology of diabetes are of utmost importance for early detection and possible prevention and early treatment from both a medical and a financial perspective. Our research group has for decades studied the pathophysiology of insulin resistance, hypertension, sympathoadrenal hyperreactivity and dyslipidaemia. We have also recently finished a long-term follow up study of subjects based on their cardiovascular and sympathetic responses to mental stress.

During 1991-2002 healthy young men recruited from the military enlistments in the Oslo/Akershus area were examined at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål. Young, healthy men, mean age of 21, were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique, which is the gold standard to assess insulin sensitivity. The present study aims to re-examine these subjects in order to investigate the influence of insulin sensitivity on development of cardiovascular risk factors and diabetes. We therefore have a unique opportunity to perform a true, long-term follow-up study of a homogenous sample of subjects of same race and gender which may provide new insights into various pathophysiological mechanisms in diabetes and cardiovascular disease including elucidating the connections between insulin resistance, changes in parameters of body build, blood pressure and sympathetic over-activity. Clarifying these mechanisms are of direct importance for the entire population. There has to our knowledge not been any previous long-term follow-up on subjects based on their insulin resistance measured with this gold standard technique.

We now want to re-examine the same subject to investigate the influence of insulin sensitivity on development of cardiovascular risk factors like blood pressure, heart rate, body build (weight, BMI, waist-hip ration, skinfold thickness), reduced insulin sensitivity, diabetes mellitus, dyslipidaemia, and sympathoadrenal activity or manifest cardiovascular disease among young men during 10-20 years of follow-up.


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Study Type : Observational
Actual Enrollment : 103 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow-up
Study Start Date : August 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort
Longitudinal Insulin Sensitivity
The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.



Primary Outcome Measures :
  1. Exploring Insulin Sensitivity After 10-20 Years of Follow-up [ Time Frame: One-day visit and the analyses will be done when all patients are examined in the period 2012-2013 ]
    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.

  2. Exploring Insulin Sensitivity After 10-20 Years of Follow-up [ Time Frame: 20 years ]
    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.


Secondary Outcome Measures :
  1. Sympathoadrenal Activity During Rest and Stress Tests [ Time Frame: One-day visit and analyses will be done during 2012-2013 ]
    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.

  2. Echocardiography [ Time Frame: One-day visit, final analyses 2012-2013 ]
    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

  3. Ultrasound Abdomen [ Time Frame: One-day visit. Final analyses of the whole cohort during 2012-2013 ]
    Ultrasound quantification of abdominal adipose tissue


Biospecimen Retention:   Samples Without DNA
whole blood, serum, white cells, urine, fat tissue cells


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
103 men previously examined with hyperinsulinemic glucose clamp, measuring insulin sensitivity, at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål.
Criteria

Inclusion Criteria:

  • Completed hyperinsulinemic glucose clamp

Exclusion Criteria:

  • Missing agreement
  • No contact information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412554


Locations
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Norway
Section of Cardiovascular and Renal Research
Oslo, Norway, 0407
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Study Director: Sverre E Kjeldsen, PhD Oslo Univeristy Hospital

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tonje Amb Aksnes, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01412554     History of Changes
Other Study ID Numbers: 2010/3339
First Posted: August 9, 2011    Key Record Dates
Results First Posted: October 10, 2019
Last Update Posted: October 10, 2019
Last Verified: September 2019
Keywords provided by Tonje Amb Aksnes, Oslo University Hospital:
Insulin resistance
Diabetes mellitus
Adipositas
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Diabetes Mellitus
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Arteriosclerosis
Arterial Occlusive Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs