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.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Paris、法国、75010
- Saint-Louis Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:横截面
队列和干预
团体/队列 |
干预/治疗 |
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control
control subjects with :
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case
Diabetic patients with :
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Show an increase in markers of ER stress in fasting patients with type 2 diabetes
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Assess whether insulin induces an increase in markers of ER stress
大体时间: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
大体时间:2 days
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2 days
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Insulin secretion in response to arginine infusion
大体时间:2 days
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2 days
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Lipolysis on insulin
大体时间:2 days
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2 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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