Identification of Human Circulating Adipocyte and Muscle Biomarkers Potentially Predictive of Diabetes Remission After Bariatric Surgery in Obese and Type 2 Diabetic Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Correlation between plasma levels of 9 target molecules and diabetes remission
研究概览
简要总结
This study focuses on identifying potentially predictive human circulating adipocyte and muscle biomarkers of diabetes remission after bariatric surgery in obese type 2 diabetic (T2D) subjects.
详细描述
The study team at the Institute of Metabolic and Cardiovascular Diseases has recently identified several potential biomarkers (secreted by skeletal muscle and adipose tissue) of glucose homeostasis control using secretomic and metabolomic analyses. The goal of this study is to assess whether the addition of 9 adipocytes and myocytes plasma level could be associated with type 2 diabetes remission one year after bariatric surgery and would improve established clinical models of prediction of diabetes remission.
Thus, obese type 2 diabetes patients undergoing bariatric surgery will have 2 blood samples, a muscle sample and one adipose tissue sample withdrawn during the study. From those samples, concentrations of 9 candidate proteins is measured : GDF6, INHBB, IL17B, TGFB2, TIMP1, VTN, MDK, GDF15, and apoM
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obese patients of at least grade 2 (body mass index ≥ 35 kg/m²)
- •Type 2 diabetics
- •About to undergo bariatric surgery at the Toulouse University Hospital
- •Affiliated or beneficiaries of a social security plan.
- •Having provided a free, informed and written consent, signed
排除标准
- •Type 1 diabetic subjects or Maturity-Onset Diabetes of the Youth.
- •Pregnant and breastfeeding women.
- •Vulnerable persons as defined in the Public Health Code: protected adults (guardianship, curators), unable to express their consent.
研究组 & 干预措施
study arm
This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.
干预措施: blood samples (Procedure)
study arm
This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.
干预措施: collection of body tissues (Procedure)
study arm
This arm consists of obese patients with type 2 diabetes who are scheduled for bariatric surgery.
干预措施: routine care procedure (Procedure)
结局指标
主要结局
Correlation between plasma levels of 9 target molecules and diabetes remission
时间窗: At 12 months post-surgery
The correlation between plasma levels of 9 target molecules (1 for each molecule) and diabetes remission will be evaluated will be evaluated through plasmatic dosages. The plasma determination of apolipoprotein M will be performed by mass spectrometry, and the 8 other molecules will be determined by the ELISA technique. The dosage is measured in mmol/l. Complete remission of T2DM will be defined according to the following criteria: HbA1c \< 5.7% and fasting blood glucose \< 5.6 mmol/l. Partial remission of T2DM will be defined as: HbA1c between 5.7 and 6.5% and fasting blood glucose between 5.6 and 6.9 mmol/l without any antidiabetic treatment. Finally, the absence of remission will include patients whose HbA1c is greater than or equal to 6.5% or fasting blood glucose greater than or equal to 7 mmol/l with one or more antidiabetic treatments.
次要结局
- Areas under the ROC curves of different logistic regression models fitted to known clinical prediction scores (DiaRem, Ad-DiaRem).(At 12 months post-surgery)
- The expression level of genes encoding 9 biomarkers in the adipocyte and the muscle cell(At 12 months after surgery)
- the kinetics of the plasma levels of each of the 9 molecules studied(At 12 months after the surgery)