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临床试验/NCT02082496
NCT02082496已完成2 期

Exploration of the Physiological Effect of GLP-1 in Obese Adults Diagnosed With Obesity Causing Genetic Mutations

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls

研究概览

简要总结

The obesity epidemic is attributable to dietary and behavioral trends acting on a person's genetic makeup to determine body mass and susceptibility to obesity-related diseases. Furthermore, common forms of obesity have a strong hereditary component and many genetic pathways that contribute to obesity have already ben identified.

Glucagon-like peptide-1 (GLP-1) is an incretin hormone that potentiates glucose-stimulated insulin secretion. However, GLP-1 also acts as an appetite-inhibiting hormone affecting the appetite center in the hypothalamus. Today, GLP-1 receptor agonists are available for the treatment of type 2 diabetes, and their treatment potential in obesity is an area of active research.

The aim of this study is to explore if the appetite inhibiting effect of GLP-1 is intact in people diagnosed with obesity causing genetic disorders and to investigate the physiological role of GLP-1 on food intake and appetite regulation in this group.

详细描述

  • Exploration of the physiological role of GLP-1 concerning food intake and appetite regulation in obese adults diagnosed with obesity related genetic disorders.
  • Assessment of the effect of GLP-1 on body composition, bone mineral density, energy expenditure, cardiac function, glucose tolerance, insulin sensitivity, lipid concentrations and neuroendocrine function.
  • Assessment of the impact of the leptin induced adaptive thermogenesis response in the weight reduced study participants.
  • Investigating the alteration of the composition of gut bacteria as well as subjective ratings of satiety and hunger before after supplement with GLP-1.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI above 28 (kg/m2)
  • age 18-65 years
  • otherwise healthy

排除标准

  • pregnancy or breastfeeding
  • Type 2 Diabetes
  • suffering from severe medical conditions
  • Recruitment for this study finished November 2015

研究组 & 干预措施

Control Group

Experimental

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

干预措施: Liraglutide (Drug)

Case Group

Experimental

4 months intervention with Liraglutide 3.0 mg daily as subcutanous injection

干预措施: Liraglutide (Drug)

结局指标

主要结局

Difference in insulin levels in reponse to GLP-1 RA treatment in obese genetic mutation carriers vs obese controls

时间窗: 4 months intervention

pmol/l

次要结局

未报告次要终点

研究者

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

Eva Pers Winning Iepsen

M.D.

University of Copenhagen

研究点 (1)

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