The Role of Glucagon-like Peptide-1 Receptor Signalling in the Glucose-lowering Effect of Increased Carbohydrate Content in the Distal Small Intestines After Meal Ingestion in 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
- 15
- 试验地点
- 1
- 主要终点
- Plasma glucose
研究概览
简要总结
Investigation of GLP-1 signalling in the glucose-lowering effect of increased carbohydrate content in the distal small intestines induced by alpha-glucosidase inhibition during meal ingestion in patients with type 2 diabetes
详细描述
The primary aim of the study is to investigate whether GLP-1 released as a result of increased carbohydrate content in the distal and L cell-rich part of the small intestine after a meal affects postprandial plasma glucose levels in patients with type 2 diabetes. This will be done by applying an alpha-glucosidase inhibitor (to increase the postprandial carbohydrate content in the distal small intestine) and the specific GLP-1 receptor antagonist exendin(9-39) (to isolate any GLP-1-mediated effects) during meal tests in patients with type 2 diabetes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least three months (diagnosed according to the criteria of the World Health Organization (WHO)) treated with metformin monotherapy
- •Caucasian ethnicity
- •Normal haemoglobin
- •Age >18 years
- •BMI >23 kg/m2 and <35 kg/m2
- •Informed and written consent
排除标准
- •Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- •Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- •Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
- •Treatment with medicine that cannot be paused for 12 hours
- •Intake of antibiotics two months prior to study
- •Treatment with glucose-lowering drugs other than metformin
- •Hypo- and hyperthyroidism
- •Treatment with oral anticoagulants
- •Active or recent malignant disease
- •Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- •Lack of effective birth control in premenopausal women
- •Positive pregnancy test on study days in premenopausal women
- •Pregnancy
- •Women who are breastfeeding
- •Any condition considered incompatible with participation by the investigators
- •If the subjects receive any antibiotic treatment while included in the study they will be excluded
研究组 & 干预措施
Acarbose
50 mg and 100 mg glucobay tablets. 2 weeks. Other name: Precose
干预措施: Acarbose (Drug)
Placebo Oral tablets
180 mg. 2 weeks.
干预措施: Placebo Oral Tablet (Drug)
Exendin (9-39)
Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.
干预措施: Exendin (9-39) (Drug)
Placbo Saline
9 mg/ml placebo saline infusion on experimental day.
干预措施: Placebo Saline (Drug)
结局指标
主要结局
Plasma glucose
时间窗: 240 min
The primary outcome is the difference between the effect of increased carbohydrate content in the distal part of the small intestine (obtained by inhibiting alpha-glucosidase with acarbose) on postprandial glucose tolerance (as assessed by area under curve (AUC) for plasma glucose during a standardised liquid mixed meal test) with and without blockade of GLP-1 signalling by exendin(9-39).
次要结局
未报告次要终点
研究者
Niels Bjørn Dalsgaard
Bachelor of Science
University Hospital, Gentofte, Copenhagen