Diabetes MellitusINFONCT01412554
Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow up
An observational study of Diabetes Mellitus and Hypertension, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Ischemic Heart Disease
- How many people
- 103 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2011to Mar 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Completed hyperinsulinemic glucose clamp
Who cannot join
- Missing agreement
- No contact information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow-up
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hypertension, Ischemic Heart Disease, Stroke
- Keywords
- Insulin resistance, Diabetes mellitus, Adipositas
- Medical subject headings
- Diabetes Mellitus, Hypertension, Myocardial Ischemia, Stroke, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal Insulin Sensitivity | The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exploring Insulin Sensitivity After 10-20 Years of Follow-up
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.
Measured: One-day visit and the analyses will be done when all patients are examined in the period 2012-2013
Exploring Insulin Sensitivity After 10-20 Years of Follow-up
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.
Measured: 20 years
Secondary outcomes (3)
Sympathoadrenal Activity During Rest and Stress Tests
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.
Measured: One-day visit and analyses will be done during 2012-2013
Echocardiography
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
Measured: One-day visit, final analyses 2012-2013
Ultrasound Abdomen
Ultrasound quantification of abdominal adipose tissue
Measured: One-day visit. Final analyses of the whole cohort during 2012-2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tonje Amb Aksnes, Oslo University Hospital
- Investigators
- Sverre E Kjeldsen, PhD, Study director, Oslo Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01412554
- Sponsor's protocol ID
- 2010/3339
- Acronym
- INFO
- Status last verified
- Sep 2019
- First submitted
- 22 Jul 2011
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Akra S, Aksnes TA, Flaa A, Eggesbo HB, Opstad TB, Njerve IU, Seljeflot I. Markers of remodeling in subcutaneous adipose tissue are strongly associated with overweight and insulin sensitivity in healthy non-obese men. Sci Rep. 2020 Aug 20;10(1):14055. doi: 10.1038/s41598-020-71109-4.
PubMed 32820223Skarn SN, Eggesbo HB, Flaa A, Kjeldsen SE, Rostrup M, Brunborg C, Reims HM, Aksnes TA. Predictors of abdominal adipose tissue compartments: 18-year follow-up of young men with and without family history of diabetes. Eur J Intern Med. 2016 Apr;29:26-31. doi: 10.1016/j.ejim.2015.11.027. Epub 2015 Dec 23.
PubMed 26712453
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow-up
- ClinicalTrials.gov ID
- NCT01412554
- Acronym / sponsor ID
- INFO / 2010/3339
- Conditions
- Diabetes Mellitus, Hypertension, Ischemic Heart Disease, Stroke
- Keywords
- Insulin resistance, Diabetes mellitus, Adipositas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Aug 2011 (estimated)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal Insulin Sensitivity | – | –The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Completed hyperinsulinemic glucose clamp
Key exclusion criteria (2 listed)
- Missing agreement
- No contact information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Sympathoadrenal Activity During Rest and Stress Tests
Time frame: One-day visit and analyses will be done during 2012-2013
Echocardiography
Time frame: One-day visit, final analyses 2012-2013
Ultrasound Abdomen
Time frame: One-day visit. Final analyses of the whole cohort during 2012-2013
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32820223Akra S, Aksnes TA, Flaa A, Eggesbo HB, Opstad TB, Njerve IU, Seljeflot I. Markers of remodeling in subcutaneous adipose tissue are strongly associated with overweight and insulin sensitivity in healthy non-obese men. Sci Rep. 2020 Aug 20;10(1):14055. doi: 10.1038/s41598-020-71109-4.
- Derived from this study: PubMed 26712453Skarn SN, Eggesbo HB, Flaa A, Kjeldsen SE, Rostrup M, Brunborg C, Reims HM, Aksnes TA. Predictors of abdominal adipose tissue compartments: 18-year follow-up of young men with and without family history of diabetes. Eur J Intern Med. 2016 Apr;29:26-31. doi: 10.1016/j.ejim.2015.11.027. Epub 2015 Dec 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sverre E Kjeldsen, PhD study director
Oslo Univeristy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus and Hypertension, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01412554, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.