- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01412554
Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow up (INFO)
Impact of INsulin Sensitivity on Cardiovascular Risk Markers During 10-20 Years of FOllow-up
Visão geral do estudo
Status
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
-
-
Oslo, Noruega, 0407
- Section of Cardiovascular and Renal Research
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Completed hyperinsulinemic glucose clamp
Exclusion Criteria:
- Missing agreement
- No contact information
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
---|
Longitudinal Insulin Sensitivity
The participants were examined using the hyperinsulinaemic isoglycaemic glucose clamp technique which is the gold standard to assess insulin sensitivity.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Exploring Insulin Sensitivity After 10-20 Years of Follow-up
Prazo: 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.
|
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
Prazo: 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.
|
20 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Sympathoadrenal Activity During Rest and Stress Tests
Prazo: 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.
|
One-day visit and analyses will be done during 2012-2013
|
Echocardiography
Prazo: 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
|
One-day visit, final analyses 2012-2013
|
Ultrasound Abdomen
Prazo: One-day visit. Final analyses of the whole cohort during 2012-2013
|
Ultrasound quantification of abdominal adipose tissue
|
One-day visit. Final analyses of the whole cohort during 2012-2013
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Sverre E Kjeldsen, PhD, Oslo Univeristy Hospital
Publicações e links úteis
Publicações Gerais
- 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.
- Skarn 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças cardiovasculares
- Doenças Vasculares
- Distúrbios do Metabolismo da Glicose
- Doenças Metabólicas
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doenças do Sistema Endócrino
- Hiperinsulinismo
- Doença cardíaca
- Doenças cardíacas
- Doença arterial coronária
- Isquemia do miocárdio
- Diabetes Mellitus
- Resistência a insulina
Outros números de identificação do estudo
- 2010/3339
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .