Postprandial Blood Glucose Control and Gastric Emptying in Patients With Type 1 Diabetes: Pathogenetic Factors, Clinical Relevance and Possible Therapeutic Options
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- gastric emptying measure
研究概览
简要总结
This study evaluates the prevalence of gastric emptying (GE) in type 1 diabetic patients (DM1) free of chronic complications in comparison with a group of healthy control subjects. The investigators will also assess the relationship between GE and glucose control (HbA1c, postprandial glucose variability), gut peptide hormones (GLP-1, GIP, and ghrelin), and gastrointestinal symptoms.
In addition, in patients with delayed GE the investigators will investigate the effect of "tailored" pre-prandial insulin bolus administered by means of insulin pump in reducing postprandial glucose variability, evaluated through continuous glucose monitoring system.
详细描述
Diabetic patients with a delayed GE will be studied in 2 separate occasions in euglycemic condition and under CGM. On both occasions, they will have to take a standard meal poor of lipids (rice 60 g; yellow squash 200 g; extra virgin olive oil 7 g; adult veal lean cuts 90 g; bananas 180 g; ordinary bread 75 g).
On the first occasion pre-prandial insulin will be administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load.
On the second occasion the amount of pre-prandial insulin will be the same as the first one test but fractioned into a double-wave bolus. The "tailored" insulin bolus will be defined according to the individual pattern of GE, as follows:
- GE T1/2 121-180 min= 60% as bolus + 40% during following 2 h
- GE T1/2 >180 min= 40% as bolus + 60% during following 4 h Glycemic variability will be assessed by the means of Continuous Glucose Monitoring System and the following indexes of glucose variability will be calculated: number of hypoglycemic events, number of hyperglycemic events, standard deviation of glycemia, glycemia variation coefficient, mean range of daily glycemia, interquartile range, M value, mean amplitude of glycemic excursions (MAGE), low blood glucose index (LBGI), high blood glucose index (HBGI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Use of insulin pump;
- •Disease duration ≥ 3 years.
排除标准
- •Presence of chronic complications of DM (including cardiovascular autonomic neuropathy);
- •BMI ≥ 30 kg/m2;
- •Presence of chronic diseases other than DM1;
- •Diseases that interfere with GE;
- •Medications that interfere with blood glucose homeostasis (except insulin) and GE.
研究组 & 干预措施
Controls
gastric emptying test gut hormones determination
干预措施: gut hormones determination (Other)
Cases
gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
干预措施: gastric emptying test (Other)
Cases
gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
干预措施: gut hormones determination (Other)
Cases
gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
干预措施: Continuous Glucose Monitoring (Other)
Cases
gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
干预措施: Insulin single bolus (Drug)
Cases
gastric emptying test gut hormones determination Continuous Glucose Monitoring Insulin single bolus Insulin double-wave bolus
干预措施: Insulin double-wave bolus (Drug)
Controls
gastric emptying test gut hormones determination
干预措施: gastric emptying test (Other)
结局指标
主要结局
gastric emptying measure
时间窗: 4 hours
次要结局
- gut hormones dosage(3 hours)
- Continuous Glucose Monitoring(7 days)
- postprandial glucose variability after single insulin bolus(3 hours)
- postprandial glucose variability after double-wave insulin bolus(3 hours)
研究者
Brunella Capaldo
MD
Federico II University