Pancreatic Enzyme Replacement and Glucose Regulation in Type 1 Diabetes
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Improvement in Glucose Regulation
研究概览
简要总结
Recent studies have demonstrated reduced pancreatic volume is present within months of T1D diagnosis in children, adolescents, and adults. As the pancreatic beta cells constitute only 1-2% of the pancreas, the degree of reduction in pancreas volume at disease onset suggests exocrine involvement, challenging the established paradigm of T1D being solely a disease of the endocrine pancreas.
To date there has not been an investigation of the potential for pancreatic enzyme replacement therapy in the management of T1D. In individuals with cystic fibrosis-related diabetes, enzyme replacement has been shown to reduce post-prandial glycemia excursions, which are reflected in improved GLP-1 responses to mixed meal tolerance testing. As post-prandial excursions and glucose variability are a significant challenge in T1D, how enzyme replacement may impact these parameters is an important question.
The investigators hypothesize that patients with T1DM who have reduced pancreatic volume will have improved glycemic responsiveness, reduced hypoglycemia, and improved symptoms of pancreatic exocrine insufficiency when treated with pancreatic enzyme replacement (CREON).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently receive care at the Eskind Diabetes Clinic at Vanderbilt University Medical Center
- •Diagnosed with T1DM for at least 12 months
- •Age over 18
- •Total daily dose of insulin greater than 0.7u/kg/day
- •Current use of a continuous glucose monitor
- •Current use of smart phone
- •Able to read and speak English
- •Willingness and ability to download and provide CGM and pump (if applicable) data
- •Reduction of pancreas volume (<0.6mL/kg body weight)
排除标准
- •History of celiac disease or inflammatory bowel disease
- •Use of medication or supplements other than insulin to control blood glucose
- •Pregnancy or breast feeding
- •Following a restrictive diet (such as very low carb diet)
研究组 & 干预措施
CREON
CREON is a pancreatic enzyme replacement
干预措施: CREON (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Glucose Regulation
时间窗: through study completion (4-5 weeks)
Mixed meal tolerance testing (MMTT) will be used to assess glucose regulation via c-peptide AUC at baseline, and after treatment with placebo and CREON in a random order.
Patient-reported Change in Pancreatic Exocrine Insufficiency (PEI) Symptoms
时间窗: through study completion (4-5 weeks)
We will use the pancreatic exocrine insufficiency questionnaire (PEI-Q) to quantitate symptoms of PEI and their relative change from baseline to after treatment with placebo and Creon in a random order. Minimum score is 0, and maximum score is 4. Higher scores correlate to worse outcome, i.e., increased abdominal symptoms and bowel movement symptoms.
次要结局
未报告次要终点
研究者
Daniel Moore
Assistant Professor of Pediatrics
Vanderbilt University Medical Center