Enteroendocrine Cells in Healthy Individuals and Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Evaluation of differences in enteroendocrine cells (density and mRNA expression) along the intestinal tract of healthy individuals compared with type 2 diabetes patients.
研究概览
简要总结
Investigation of the anatomical distribution of enteroendocrine cells by a systematic approach along the entire human intestinal tract in healthy individuals and patients with type 2 diabetes.
详细描述
Enteroendocrine K and L cells are pivotal in regulating appetite and glucose homeostasis, but knowledge of their distribution in man is sparse and it is unknown whether alterations occur in type 2 diabetes. Twelve patients with type 2 diabetes and 12 age and BMI-matched healthy individuals underwent upper and lower double-balloon enteroscopy with mucosal biopsy retrieval from every ~30 cm of the small intestine and specific locations in the large intestine. The investigators evaluated the distribution of enteroendocrine cells (using IHC staining for their specific hormonal products) and evaluated mRNA expression of the corresponding genes along the entire intestinal tract in patients with type 2 diabetes and in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes patients
- •Diagnosis of type 2 diabetes (at least 3 months prior to study inclusion)
- •Treatment with diet counseling alone or combined with an glucose-lowering drugs: metformin or sulphonylurea
- •Caucasian ethnicity
- •Age >25 and <70 years
- •Normal hemoglobin
- •Negative for autoantibodies to glutamic acid decarboxylase (GAD-65) and islet cell autoantibodies (ICA).
- •Healthy individuals
- •Fasting plasma glucose <6.0 mM
- •Plasma glucose 2 hours after a 75 g-oral glucose tolerance test <7.8 mM
- •Negative for GAD-65 antibodies and ICA
- •Caucasian ethnicity
- •Age >25 and <70 years
- •Normal hemoglobin
排除标准
- •Type 2 diabetes patients
- •Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase >2 times normal value)
- •Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
- •Previous hysterectomy, appendectomy, cholecystectomy or caesarean
- •Sleep apnea
- •American Society of Anesthesiologists class >3
- •Allergy to soy protein or eggs
- •BMI >35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy.
- •Healthy individuals
- •Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase >2 times normal value)
- •Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase >2 times normal value)
- •Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
- •Previous hysterectomy, appendectomy, cholecystectomy or caesarean
- •Sleep apnea
- •American Society of Anesthesiologists class >3
- •Allergy to soy protein or eggs
- •BMI >35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy
- •First-degree relative(s) with type 1 or type 2 diabetes.
结局指标
主要结局
Evaluation of differences in enteroendocrine cells (density and mRNA expression) along the intestinal tract of healthy individuals compared with type 2 diabetes patients.
时间窗: Cross-sectional study. Each participant went through two study days (upper and lower double-ballon enteroscopy, respectively)
Using a double-balloon enteroscopy device, mucosal biopsies are obtained from the entire intestinal tract in 12 healthy individuals and 12 patients diagnosed with type 2 diabetes. The biopsies are analysed using immunohistochemistry (IHC) and mRNA expression analysis. Positively stained enteroendocrine cells (from IHC) are counted and divided by the epithelial area providing 'density' (cells/mm2). Cell count (density) and mRNA expression data obtained from the healthy individuals and type 2 diabetes patietns are compared to evaluate potential differences between the two groups.
Evaluation of enteroendocrine cells (density and mRNA expression) in the intestinal tract.
时间窗: Cross-sectional study. Each participant went through two study days (upper and lower double-ballon enteroscopy, respectively)
Using a double-balloon enteroscopy device, mucosal biopsies are obtained from the entire intestinal tract in 12 healthy individuals and 12 patients diagnosed with type 2 diabetes. The biopsies are analysed using immunohistochemistry (IHC) and mRNA expression analysis. Positively stained enteroendocrine cells (from IHC) are counted and divided by the epithelial area providing 'density' (cells/mm2). The data obtained from cell count and mRNA expression analysis present the variation in number of enteroendocrine cells (density) and the expression of hormonal products along the intestinal tract.
次要结局
未报告次要终点
研究者
Filip Krag Knop
MD, PhD, professor
University Hospital, Gentofte, Copenhagen