Glucagon Efficiency After High and Low Carbohydrate Diet
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incremental area under the glucose curve
研究概览
简要总结
No studies have investigated if the dietary composition of carbohydrate influences the glycaemic effect of single and multiple boluses of subcutaneous low-dose glucagon. Further, the recommended diet composition to patients with type 1 diabetes has not been thoroughly validated. Many patients with type 1 diabetes practice low carbohydrate eating patterns due to the assumption that this diet can reduce fluctuations in plasma glucose. Before glucagon can be used as an add-on to intensive insulin treatment, these aspects need to be elucidated. The purpose of this study is to determine, whether diet composition of carbohydrate affects the glycogen stores in the liver and affects the glucose response of glucagon during hypoglycaemia.
HYPOTHESIS: In patients with type 1 diabetes, the glucose response of a single bolus of low-dose glucagon is not associated with diet carbohydrate content.
AIM: The aim is to investigate how one week of high- compared to low-carbohydrate diet influence the glycaemic response of low-dose glucagon in patients with insulin pump treated type 1 diabetes. The secondary aim is to investigate how two dietary intervention weeks differ in the incidence of hypoglycaemia, postprandial hyperglycaemia, and daily glucose excursions.
DESIGN:A non-blinded two-way cross-over, randomized study will be conducted. After participants have given an informed consent, they will go through four steps: 1) screening visit 2) Run-in period, 3) first meal intervention for one week finalizing with one study visit and 4) second meal intervention for one week finalizing with another study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70 years
- •T1D ≥ 3 year
- •BMI 20-27 kg/m2
- •CSII ≥ 1 year
- •HbA1c < 69 mmol/mol (8.5 %)
- •C-peptide negative (< 60 pmol/l)
- •Hypoglycemia awareness (self-reported)
- •Use of carbohydrate counting and the insulin pump bolus calculator for all meals
排除标准
- •Allergy or intolerance to lactose or Glucagen®(Novo Nordisk, Bagsværd, DK)
- •Impaired renal function (eGFR < 60 ml/min/1.73m2)
- •Liver disease with ALAT > 2.5 times the upper limit of the reference interval
- •Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- •Known or suspected alcohol or drug abuse
- •Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- •Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.
- •Inability to understand the patient information and to give informed consent.
结局指标
主要结局
Incremental area under the glucose curve
时间窗: 0-240 minutes
Peak glucose value
时间窗: within 240 minutes
次要结局
- Plasma glucose variation(Two weeks)
- Katekolamine concentration(0-240 min.)
- Free fatty acids concentration(0-240 min.)
- Headache(0-240 min.)
- Glucagon concentration(0-240 min.)
- Ketone bodies concentration(0-240 min.)
- Hypoglycemia symptoms(0-240 min.)
- Vomit(0-240 min.)
- Insulin concentration(0-240 min.)
- Triglycerides concentration(0-240 min.)
- Nausea(0-240 min.)
研究者
Ajenthen Ranjan
MD, PhD student
Hvidovre University Hospital