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临床试验/NCT00809029
NCT00809029Unknown不适用

The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Hormone Sensitive Lipase, Lipoprotein Lipase And Adipokine Expression In Human Subcutaneous Adipose Tissue: An In Vivo Study

Liverpool University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue

研究概览

简要总结

Study part-1

GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. Data emerging from studies in animal models and cultured human fat cells support a physiological role for GIP in the adipose tissue metabolism which may contribute to the pathogenesis of obesity.

The proposed study will shed more light on the interactions between gut hormones and adipose tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from all subjects during both visits, once in the basal state (before the start of the peptide/placebo infusion) and then repeated at the end of the period of infusion.

Study part-2

Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from the physiological intestinal routes with subsequent profound modification of gut hormone secretion

We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal role in the improvement and/or restoration of diabetes, we propose to study patients (both sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be compared to those of BMI matched control subjects with normal glucose tolerance

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance
  • Obese (BMI >30 kg/m2) subjects also with normal glucose tolerance.
  • Obese with impaired glucose tolerance
  • Obese with diet controlled diabetes mellitus
  • Morbid obesity, type diabetes and post bariatric surgery (study part 2)

排除标准

  • History of severe cardiac, hepatic or renal disease
  • Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction)
  • Current malignant disease
  • Known alcohol misuse
  • Major psychiatric disease (including current use of antidepressants)
  • History of major eating disorder (anorexia or bulimia nervosa)

结局指标

主要结局

To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue

时间窗: Before and after 4 hours of infusion

次要结局

  • To determine the role of GIP in adipocytokine gene expression and secretion from human subcutaneous adipose tissue(Baseline and after 4 hours of continuous infusion)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

DR CHRISTINA DAOUSI

Clinical Senior Lecturer

Liverpool University Hospitals NHS Foundation Trust

研究点 (2)

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