Amylin and GLP-1: Influence on Gastric Emptying, Appetite and Food Intake in Humans.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
研究概览
简要总结
The aim of this proposal is to dissect the mechanisms controlling gastric emptying, appetite and food intake in humans, and to obtain new knowledge to fight obesity on a pharmacological basis.
详细描述
The objective of the present study is to elucidate the mechanisms behind the effects of glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite and food intake. The first GLP-1 based anti-diabetic therapy was approved by the FDA in 2005 and is now on the market in the United States. The strong glucose-dependent insulinotropic property of GLP-1 is a highly attractive feature in the pursue of optimal glycaemic control in type 2 diabetes. Moreover, the potential of GLP-1 to reduce gastric emptying, appetite and food intake makes it an attractive tool in the fight against obesity, a pandemic condition that often leads to type 2 diabetes, and several companies are developing weight lowering drugs based on GLP-1. Interestingly, another peptide, amylin, exerts very similar effects on gastric emptying, appetite and food intake in humans. Amylin is found in insulin-rich granules in pancreatic beta-cells and is co-secreted with insulin upon insulinotropic stimuli. Currently, it is not known whether the inhibiting effects of GLP-1 on gastric emptying, appetite and food intake are directly mediated by GLP-1, or if the effects are secondary to the robust insulin responses, and thereby amylin responses, elicited by GLP-1. The objective of the present study is therefore to further elucidate the mechanisms of these effects in order to strengthen the development of anti-diabetic drugs with potential weight lowering capabilities.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with type 1 diabetes
- •Informed oral and written consent
- •Caucasians over the age of 18 years with type 1 diabetes (diagnosed according to the criteria of WHO) receiving long acting insulin
- •C-peptide negative glucagon test
- •Normal blood haemoglobin concentration
- •Healthy control subjects
- •Informed oral and written consent
- •Caucasians over the age of 18 years
- •Normal 75 g- oral glucose tolerance test (OGTT) according to the criteria of WHO
- •Negative islet cell autoantibodies (ICA) and GAD-65 autoantibodies
- •No first-degree relatives with diabetes
- •Normal blood haemoglobin concentration
排除标准
- •Patients with type 1 diabetes
- •Residual beta-cell function (evaluated with glucagon test)
- •Impaired hepatic function (aspartate aminotransferase (ASAT) and/or alanine aminotransferase (ALAT) > 2 times upper normal limit)
- •Diabetic nephropathy (serum-creatinine > 130 µM and/or albuminuria)
- •Diabetic neuropathy
- •Proliferative diabetic retinopathy
- •Pregnancy, breastfeeding or intention of becoming pregnant or judged to be using inadequate contraceptive measures
- •Healthy control subjects
- •Impaired hepatic function (ASAT or ALAT > 2 times upper normal limit)
- •Impaired renal function (serum-creatinine > 130 μM and/or albuminuria)
- •First-degree relatives with diabetes
- •Pregnancy, breastfeeding or intention of becoming pregnant or judged to be using inadequate contraceptive measures