A Glucometabolic Evaluation of Patients With Idiopathic Ketotic Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plasma glucose
研究概览
简要总结
The project will evaluate 1) the postprandial metabolism and 2) continuous glucose levels in subjects diagnosed with Idiopathic Ketotic Hypoglycemia (IKH)) and healthy control subjects.
详细描述
IKH is a common, but not fully understood, condition in children, and in some the condition may persist in adulthood. In the present study we seek to evaluate the postprandial metabolism in adult subjects diagnosed with IKH through a clinical study including:
- two test days, where the subjects completes a) an oral glucose tolerance test (OGTT) and b) a miced meal test (MMT). Before, during and after ingestion of the OGTT/MMT, blood samples will be frequently drawn for the evaluation of plasma glucose, hormones, amino acids and more. During both tests, the subjects will recieve a continuous infusion of primed glucose tracer to further evaluate the glucose metabolism.
- a 14-day period where the subjects will lead the usual lives, wearing a continuous glucose monitor (CGM). This will enable us to evaluate long-term differences in plasma glucose levels in IKH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •IKH-participants:
- •Verified diagnosis of IKH by health professional
- •BMI of 18-30 kg/m2
- •Normal liver- and kidney function
- •informed consent
- •Healthy control participants
- •Normal glucose tolerance
- •BMI of 18-30 kg/m2
- •Normal liver- and kidney function
- •informed consent
排除标准
- •A history of diabetes
- •close family members with diabetes
- •use of drugs affecting the glucose metabolism that cannot be paused
- •any condition that the study investigators deem unacceptable for participation
- •pregnancy or breastfeeding.
结局指标
主要结局
Plasma glucose
时间窗: -120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes
The intergroup difference in peak to nadir difference in plasma glucose following OGTT/MMT
Time in range (CGM)
时间窗: 0-14 days of CGM-period
The intergroup difference in time spend in glycemic range, measured by CGM
次要结局
- Glucose-dependent insulinotropic polypeptide (GIP)(-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes)
- Amino acids(-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes)
- Glucagon(-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes)
- Glucagon like peptide-1 (GLP-1)(-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes)
- Risk of hypoglycemia(0-14 days of CGM-period)
- Insulin(-120,-60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes)
- Coefficients of variation (CV) of plasma glucose(0-14 days of CGM-period)
- Endogenous glucose production(-120,, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes)
- Glucose revomal(-120, -60, -30, 0, 15, 30, 45, 60, 90, 120, 150, 180 minutes)
- Mean plasma glucose(0-14 days of CGM-period)
研究者
Magnus Frederik Gluud Grøndahl
Principal investigator, Medical Doctor, PhD student
University Hospital, Gentofte, Copenhagen