NCT03195257已完成不适用
Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- C-terminal telopeptide of type I collagen (CTX).
研究概览
简要总结
Investigate GIP effects on biomarkers involved in bone homeostasis
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, Care Provider, Investigator)
盲法说明
Randomized, double-blinded, cross-over study with 5 study days.
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 (positive islet cell/ glutamic acid decarboxylase-65 antibodies)
- •Patients without measurable beta cell function (i.e. incremental C-peptide below detection limit (<0.16 nmol/l) following an 5 g-iv-arginine stimulation test,
排除标准
- •HbA1c >9% (75 mmol/mol),
- •standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio);
- •an abnormal state of hypoglycemia awareness,
- •significant diabetic complications (i.e. proliferative diabetic retinopathy, neuropathy, severe atherosclerosis, heart disease) and,
- •treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.
研究组 & 干预措施
Hypoglycemia-GLP-1
Active Comparator
干预措施: GLP-1 (Other)
结局指标
主要结局
C-terminal telopeptide of type I collagen (CTX).
时间窗: 30 minutes intervals, time 0 up to 120 min
次要结局
- N-terminal propeptide of type 1 procollagen (P1NP).(30 minutes intervals, time 0 up to 120 min)
- Parathyroid hormone (PTH)(30 minutes intervals, time 0 up to 120 min)
研究者
Mikkel Christensen
Associate Professor, Principal Investigator
University Hospital, Gentofte, Copenhagen
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