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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01412554
First received: July 22, 2011
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

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
Diabetes Mellitus
Hypertension
Ischemic Heart Disease
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow-up

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Insulin sensitivity measured with 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 ] [ Designated as safety issue: No ]
    Longitudinal study of a cohort of young men, first follow-up after 10-20 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:
  • Sympathoadrenal activity during rest and stress tests [ Time Frame: One-day visit and analyses will be done during 2012-2013 ] [ Designated as safety issue: No ]
    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.

  • Echocardiography [ Time Frame: One-day visit, final analyses 2012-2013 ] [ Designated as safety issue: No ]
    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

  • Ultrasound abdomen [ Time Frame: One-day visit. Final analyses of the whole cohort during 2012-2013 ] [ Designated as safety issue: No ]
    Ultrasound quantification of abdominal adipose tissue


Biospecimen Retention:   Samples Without DNA

whole blood, serum, white cells, urine, fat tissue cells


Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Young caucasian men
During 1991-96 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. A total of 158 young men, mean age of 21, were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

158 healthy young men measured insulin sensitivity at Center of Cardiovascular and Renal Research, Division of Medicine, Oslo University Hospital, Ullevål in the period 1991-2002.

Criteria

Inclusion Criteria:

  • Completed hyperinsulinemic glucose clamp

Exclusion Criteria:

  • Missing agreement
  • No contact information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412554

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

Additional Information:
No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01412554     History of Changes
Other Study ID Numbers: 2010/3339
Study First Received: July 22, 2011
Last Updated: February 10, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
Insulin resistance
Diabetes mellitus
Adipositas

Additional relevant MeSH terms:
Coronary Artery Disease
Diabetes Mellitus
Heart Diseases
Hypertension
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014