Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Response to sitagliptin
研究概览
简要总结
This pilot study will be conducted in adolescents with cystic fibrosis (CF) without diabetes but with abnormal glucose tolerance, and will assess the effects of sitagliptin on glucose regulation. An oral glucose tolerance test (OGTT) and a mixed meal tolerance test (MMTT), will be performed at baseline and again ~4 weeks after treatment with study drug. We will also look at blood sugars throughout the day using a continuous glucose monitor (CGM) before each time the MMTT/OGTT are performed. Several hormones that may affect the way the body regulates blood sugars will be measured in blood when the OGTT and MMTT are done. We will assess the effect this medicine has on blood sugars (using CGM) and the effect the medicine has on the hormones measured during the OGTT and MMTT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CF between 13 and <21 yrs old
- •Known impaired or indeterminate glucose tolerance (based on a prior OGTT)
- •No history of CFRD
排除标准
- •Insulin use in the last two months
- •Acute pulmonary exacerbation / oral corticosteroid use in the last 6 weeks
- •History of pancreatitis in the last 12 months
- •Skin rashes or conditions that may affect CGM placement and wear
- •Pregnancy or intent on becoming pregnant
- •Patients on growth hormone therapy
- •Renal insufficiency with creatinine clearance <50 ml/min (based on Schwartz formula)
研究组 & 干预措施
Sitagliptin
Treatment with sitagliptin
干预措施: Sitagliptin (Drug)
结局指标
主要结局
Response to sitagliptin
时间窗: Change from baseline to ~4 weeks of study drug
Change in incretin (glucagon like peptide 1; glucose-dependent insulinotropic polypeptide) concentrations in response to study drug.
次要结局
- Beta-cell function(Change from baseline to ~4 weeks of study drug)
- Continuous glucose monitoring (CGM)(change from baseline to ~4 weeks of study drug)
研究者
Larry Fox
Pediatric Endocrinologist
Nemours Children's Clinic