- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00674271
Immune Profile and Complication Risk in Type 2 Diabetes (IMPACT)
Immune Profile and Complications Risk in Type 2 Diabetes
The aim of this study is to investigate the relation between individual differences in pattern recognition molecules (PRM's) in the innate immune system and the prevalence and development of vascular complications in patients with type 2 diabetes.
This is based on the hypothesis that pattern recognition molecules (PRM's) in the innate immune system contributes to a chronic low grade inflammation in diabetic patients. Variation in PRM's - at the genome, proteome as well as the functional level - are therefore associated with the degree of chronic low grade inflammation, and probably also with the prevalence of vascular complications.
연구 개요
상태
정황
상세 설명
Aim: The primary aims of the project are:
- By use of advanced magnetic resonance imaging to characterize the prevalence of atherosclerosis in the carotid arteries in patients with newly diagnosed type 2 diabetes.
- To investigate if individual differences in the innate immune system contributes to the prevalence and development of cardiovascular disease in patients with type 2 diabetes.
- To prospectively observe the cardiovascular morbidity and mortality in a cohort of patients with type 2 diabetes seen in the light of the obtained baseline characteristics.
Background: Type 2 diabetes is a very common disease in the western world. Patients with type 2 diabetes are at risk of a number of complications, including macroangiopathy which involves an accelerated atherosclerosis, that causes most of the increased mortality and morbidity in type 2 diabetics. Mounting evidence suggests that development of vascular complications is associated to a chronic low grad inflammation in type 2 diabetes. Individual differences in the innate immune system might contribute to this chronic low grade inflammation as it has become apparent that in some situations - as after tissue ischemia or in diabetes - a change in the body's own cell glycosylations occurs, which leads to increased affinity of PRM's. This study will focus primarily on two families of PRM's: Collectins and Toll-like receptors.
Methods: The study consists of a prospective observational cohort study of 100 newly diagnosed type 2 diabetic patients with continuous 2-year clinical follow-up and a register-based follow-up of morbidity and mortality study after 5 and 10 years. Furthermore 100 healthy control subjects will be included. Baseline data will represent a independent cross-sectional study of the relationship between the innate immune system, glycemic control and the presence of atherosclerosis in the carotid arteries in newly diagnosed type 2 diabetic patients.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Aarhus C, 덴마크, 8000
- Medical Department M, Aarhus University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
100 patients with newly diagnosed (<5 years since diagnosis) type 2 diabetes referred from general practitioners to Medical Department M, Aarhus University Hospital, Denmark.
100 healthy (no diabetes or prediabetes in oral glucose tolerance test) control subjects matched for age and gender.
설명
Inclusion Criteria:
- Diabetics: Newly diagnosed (<5 years since diagnoses) type 2 diabetes due to national diagnosis criteria
- Controls: No diabetes or prediabetes in oral glucose tolerance test
Both:
- Age > 18 years
- Signed informed consent
Exclusion Criteria:
Both:
- Pacemaker or other magnetic materials in the body
- Severe claustrophobia
- Pregnancy/lactation
- Cancer - former or current
- Acute or chronic infection
- Dialysis-dependent kidney disease
공부 계획
연구는 어떻게 설계됩니까?
코호트 및 개입
그룹/코호트 |
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Diabetics
100 patients with newly diagnosed (<5 years since diagnosis) type 2 diabetes referred from general practitioners to Medical Department M, Aarhus University Hospital, Denmark.
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Controls
100 healthy (no diabetes or prediabetes in oral glucose tolerance test) control subjects matched for age and gender
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Plaque burden in carotid arteries
기간: Individual
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Individual
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2차 결과 측정
결과 측정 |
기간 |
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Serum levels of pattern recognition molecules
기간: Individual
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Individual
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Genotyping genes for pattern recognition molecules
기간: Individual
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Individual
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jens S Christiansen, Prof., MD, Medical Department M, Aarhus University Hospital, Denmark
간행물 및 유용한 링크
일반 간행물
- Laugesen E, Hoyem P, Fleischer J, Kumarathas I, Knudsen ST, Hansen KW, Christiansen JS, Hansen TK, Poulsen PL. Reduced Subendocardial Viability Ratio Is Associated With Unfavorable Cardiovascular Risk Profile in Women With Short Duration of Type 2 Diabetes. Am J Hypertens. 2016 Oct;29(10):1165-72. doi: 10.1093/ajh/hpw066. Epub 2016 Jul 12.
- Funck KL, Laugesen E, Hoyem P, Fleischer J, Cichosz SL, Christiansen JS, Hansen TK, Poulsen PL. Low Physical Activity Is Associated With Increased Arterial Stiffness in Patients Recently Diagnosed With Type 2 Diabetes. Am J Hypertens. 2016 Jul;29(7):882-8. doi: 10.1093/ajh/hpv197. Epub 2015 Dec 28.
- Fleischer J, Lebech Cichosz S, Hoeyem P, Laugesen E, Loegstrup Poulsen P, Sandahl Christiansen J, Tarnow L, Hansen TK. Glycemic variability is associated with reduced cardiac autonomic modulation in women with type 2 diabetes. Diabetes Care. 2015 Apr;38(4):682-8. doi: 10.2337/dc14-0654. Epub 2015 Jan 8. Erratum In: Diabetes Care. 2015 Nov;38(11):2188.
- Laugesen E, Hoyem P, Christiansen JS, Knudsen ST, Hansen KW, Argraves WS, Hansen TK, Poulsen PL, Rasmussen LM. Plasma levels of the arterial wall protein fibulin-1 are associated with carotid-femoral pulse wave velocity: a cross-sectional study. Cardiovasc Diabetol. 2013 Jul 18;12:107. doi: 10.1186/1475-2840-12-107.
- Laugesen E, Hoyem P, Stausbol-Gron B, Mikkelsen A, Thrysoe S, Erlandsen M, Christiansen JS, Knudsen ST, Hansen KW, Kim WY, Hansen TK, Poulsen PL. Carotid-femoral pulse wave velocity is associated with cerebral white matter lesions in type 2 diabetes. Diabetes Care. 2013 Mar;36(3):722-8. doi: 10.2337/dc12-0942. Epub 2012 Nov 5.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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