Role of Endoplasmic Reticulum Stress in the Pathophysiology of Type 2 Diabetes (GLUCOSTRESS)
The purpose of this study is to investigate whether Endoplasmic Reticulum (ER) stress pathway is activated in peripheral tissues (adipose tissue) in insulin resistant diabetic patients compared to healthy subjects normoglycemic matched for age and sex an to investigate whether ER stress pathway can be activated in response to insulin. Indeed, some preliminar on rates studies shows that ER stress pathway is activated by insulin in liver and adipose tissue showing that hyperinsulinemia might help trigger stress path ER.
For this, we propose a case control study of type 2 diabetic patients vs control subjects in which markers of ER stress will be evaluated from abdominal subcutaneous adipose tissue obtained before and after euglycemic hyperinsulinemic. We chose to consider adipose tissue subcutaneous rather than visceral adipose tissue for obvious reasons of lesser invasiveness.
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Paris, 프랑스, 75010
- Saint-Louis Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Specific criteria for diabetic patients:
- Having type 2 diabetes for at least 6 months
- HbA1c ≤ 8%
- Treated by lifestyle and dietary rules associated or not to a hypoglycemic therapy (metformin and / or sulfamid) and / or insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4): Vildagliptin, Sitagliptin, Saxagliptin
- No modification of hypoglycemic therapy and / or insulin secretors for at least 3 months
Specific criteria for control subjects:
- Nondiabetic subjects (fasting blood glucose <7.0 mmol / l without hypoglycemic treatment).
- The control subjects should be matched to patients for age (± 5 years), sex, and BMI (± 2 kg/m2).
Common criteria for patients and control subjects:
- Aged 18 to 60 years
- Body Mass Index between 25 and 35 kg/m2
- Accepting the constraints of the protocol and who signed the informed consent
- Systolic blood pressure < 160 mmHg, diastolic blood pressure < 90 mm Hg (with or without antihypertensive treatment)
- Resting heart rate between 55 and 100 beats/min.
- Normal laboratory tests or not clinically significant abnormality for NFS platelets, PT, aPTT, fibrinogen ALT, AST, GGT, Serum electrolytes, urea, creatinine, Uric acid Triglycerides, total cholesterol, HDL cholesterol
- HCG negative blood (for female subjects)
- Affiliated to the Social Security.
Exclusion Criteria:
- Current infections or recent infections (<10 days)
- Neoplastic disorders (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), haematological, cardiovascular, psychiatric, neurological
- Poisoning smoking (>10 cigarettes per day, what ever the duration of intoxication)
- Treatment with insulin or glitazones Pregnancy, Breastfeeding
- Body Mass Index > 35 kg/m2
- Any drug taken for less than 8 days without the inclusion of minor analgesics (aspirin, paracetamol), anti-hypertensive medications, oral hypoglycemic (metformin and sulphonylureas) and insulin secretors dependent glucose as inhibitors of DPP4 (dipeptidyl peptidase-4) and oral contraceptives.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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control
control subjects with :
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case
Diabetic patients with :
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Show an increase in markers of ER stress in fasting patients with type 2 diabetes
기간: 2 days
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Protein expression markers of ER stress pathway BiP / GRP 78, CHOP, ATF4 EDEM and XBP-1
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2 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Assess whether insulin induces an increase in markers of ER stress
기간: 2 days
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Insulin sensitivity
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2 days
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Insulin secretion in response to glucose infusion
기간: 2 days
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2 days
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Insulin secretion in response to arginine infusion
기간: 2 days
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2 days
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Lipolysis on insulin
기간: 2 days
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2 days
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
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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