The Effect of Glucagon Like Peptide-1 (GLP-1) on Glycaemic Profile and Eating Behaviour Following Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Nadir Blood Glucose
研究概览
简要总结
Patients who have undergone gastrectomy (removal of the stomach) to treat or prevent cancer are known to have a significantly reduced quality of life. To date, there is very little information on the physiological causes of this. The investigators suspect that overproduction of a hormone (chemical) called glucagon like peptide-1 (GLP-1) released by the lining of the gut may play a role in the reduced appetite, weight loss and low blood sugar symptoms seen in this group. To investigate this, the investigators will study the response of 16 patients who have previously had a gastrectomy to a glucose drink, and a meal, while receiving an infusion of a specific blocker of GLP-1 or placebo. The investigators will examine the levels of sugar and associated hormones in the blood, food consumption and food reward behaviour using standard tools.
Participants will be invited to attend the Clinical Research Facility at Addenbrooke's Hospital for a screening visit, and two whole day study visits. The study has been designed to assess the role of overproduction of GLP-1 by completely blocking its actions, rather than assess the use of the blocking compound as a medication, and is therefore regarded as a physiological study, not a clinical trial.
The goal of this study is to demonstrate the magnitude of effect of GLP-1 on blood sugar and appetite derangement in patients who have had a gastrectomy. This will guide future work on the development of novel treatment paradigms for the post-gastrectomy patient group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• At least 3 months post completion of treatment for gastric cancer, or prophylactic gastrectomy
- •Aged at least 18 years
- •Able to tolerate an oral glucose tolerance test
- •Able to understand and retain all information regarding the study and give informed consent.
- •Willing to receive an infusion of human albumin solution
排除标准
- •• Have a diagnosis of diabetes
- •Have a history of untreated anaemia in the last 3 months
- •Be aged under 18 years
- •Have active gastric cancer
- •Be pregnant or attempting to conceive
研究组 & 干预措施
Placebo
Infusion of 1% human albumin in normal saline.
干预措施: Placebo (Other)
Exendin
Infusion of Exendin 9-39 in 1% human albumin in normal saline
干预措施: Exendin 9-39 (Other)
结局指标
主要结局
Nadir Blood Glucose
时间窗: As assessed during a 50g glucose tolerance test while receiving infusion of GLP-1 antagonist. At time 30-120 minutes of infusion of Exendin 9-39.
Lowest blood sugar reading during an oral glucose tolerance test while receiving infusion of GLP-1 antagonist. Please note participants will receive infusion of active compound for a maximum of four hours, with no expected effect of compound persisting for more than 30 minutes post-infusion.
次要结局
- Total Insulin Secretion(Samples collected at 0, 15, 30, 45 and 60 minutes post oral glucose tolerance test.)
- Eating Rate During ad Libitum Meal(150-210 minutes during infusion of Exendin 9-39 or placebo.)
- Number of Participants With Infusion Related Adverse Events as Assessed by CTCAE v4(24 hours from onset of infusion.)
- Decreased Hunger and Satiety Ratings During and After ad Libitum Meal(150-240 minutes during infusion of Exendin 9-39 or placebo and for 4 hours post-cessation of infusion.)
- Altered Food Attention.(0-240 minutes during infusion of Exendin 9-39 or placebo, assessed on four occasions (baseline or T0, post-OGTT, pre-meal, post-meal) using a validated dot-probe visual response tool and reported in response time (milliseconds).)
- Altered Food Motivation(0-240 minutes during infusion of Exendin 9-39 or placebo (baseline or T0, post-OGTT, pre-m, assessed on four occasions using a validated grip strength surrogate of food motivation and measured as the area under the curve of a grip force monitoring curve.)
- Total Meal Consumption(150-210 minutes during infusion of Exendin 9-39 or placebo)
研究者
Geoffrey Roberts
Clinical Research Associate
Cambridge University Hospitals NHS Foundation Trust