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临床试验/NCT02810691
NCT02810691已完成不适用

The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis

Institut de Recherches Cliniques de Montreal1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
试验地点
1
主要终点
Plasma glucose area under the curve

研究概览

简要总结

With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi systemic disease, continue to evolve. A major emerging complication is CF related diabetes (CFRD) which is occurring in 40-50% of adults. Patients who develop CFRD are at increase risk of morbidity and mortality and they are also facing an increased medical burden with insulin therapy, the only recommended treatment. Accelerated decline in weight and/or pulmonary function start 2 to 4 years before CFRD onset and this period is characterized by frequent Post-Prandial Glycemic (PPG) excursions. Higher PPG excursions are associated with lower pulmonary function and it predicts future CFRD risk. To the improved nutritional status, lung function and survival of patients, the nutritional approach for patients with CF focuses on high-energy high-fat diet and a pancreatic enzyme supplementation. However, such diet also contributes to increased PPG excursions. Based on the beneficial effects of nutrition therapy to improve PPG in other forms of pre-diabetes and diabetes, extending such benefits to patients with CF is important. The investigators aim to test the feasibility and the effectiveness of a viscous fiber supplement to reduce PPG in adult patients with CF. Using a randomized crossover design, the investigators will study the impact of two doses of a viscous fiber supplement as compared to a placebo.

详细描述

With improved survival, the clinical spectrum of cystic fibrosis (CF), a complex multi systemic disease, continue to evolve. A major emerging complication is CF related diabetes (CFRD). CFRD is a major co-morbidity occurring in 20% of adolescents and 40-50% of adults and is mainly due to reduced insulin secretion. Patients who develop CFRD are at increase risk of morbidity and mortality and they are also facing an increased medical burden with insulin therapy, the only recommended treatment. Because accelerated decline in weight and/or pulmonary function start 2 to 4 years before CFRD onset and that this period is characterized by frequent Post-Prandial Glycemic (PPG) excursions, the role of these PPG excursions in clinical deterioration have been investigated. The investigators have shown that higher PPG excursions are associated with lower pulmonary function and others have shown that PPG excursions predicts future CFRD risk. Food overconsumption is discouraged in other forms of diabetes to avoid overweight or obesity, but also to prevent an increase in insulin demand. In contrast, nutritional approach for patients with CF focuses on high-energy high-fat diet to meet increased energy requirements. In combination with an appropriate pancreatic enzyme supplementation, this approach contributes significantly to the improved nutritional status, lung function and survival of patients. However, such diet also contributes to increased PPG excursions. Based on the beneficial effects of nutrition therapy to improve PPG in other forms of pre-diabetes and diabetes, extending such benefits to patients with CF is important. In the context of high CF treatment burden, such approach should however be simple and not inducing weight loss. The investigators aim to test the feasibility and the effectiveness of a viscous fiber supplement to reduce PPG in adult patients with CF. Using a randomized crossover design, the investigators will study the impact of two doses of a viscous fiber supplement as compared to a placebo in controlled conditions, in 22 patients, over 8 hours, at the research center with 2 standardized mixed-meals: breakfast and lunch on PPG excursions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, 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

  • •Diagnosed with CF
  • •Aged above 18 years
  • •CF-Impaired glucose tolerance, CF-indeterminate glucose tolerance (INDET), de-novo diabetes not requiring immediate treatment and diabetes without pharmacological treatment, based on the oral glucose tolerance test (OGTT) performed within three months of the first visit

排除标准

  • •Treated or longstanding CFRD
  • •Subjects taking medication or affected by conditions that could interfere with glucose metabolism in the last 6 weeks: hemoptysis, fever, IV antibiotic treatment, pregnancy and oral steroids. If a patient presents any sign of infection confirmed by a trained CF pneumologist, OGTT testing is postponed to the next medical appointment 1 months later.
  • •Subjects with severe gastrointestinal disease (Crohn disease, coeliac disease and recent (<1 year) history of intestinal occlusion).
  • •Subjects with intestinal obstruction history.
  • •Allergy to an ingredient in the menu.
  • •Corrector or potentiator prescribed within the last 6 months prior to the first visit.

研究组 & 干预措施

Soluble fiber, dose #1

Active Comparator

Soluble fiber supplementation with dose #1 (smaller dose) of psyllium fiber.

干预措施: Soluble fiber supplementation (Dietary Supplement)

Soluble fiber, dose #2

Active Comparator

Soluble fiber supplementation with dose #2 (bigger dose) of psyllium fiber.

干预措施: Soluble fiber supplementation (Dietary Supplement)

Placebo

Placebo Comparator

A 250 ml placebo solution of orange-flavored water will be drink at breakfast.

干预措施: Placebo (for fiber supplementation) (Dietary Supplement)

结局指标

主要结局

Plasma glucose area under the curve

时间窗: 3 hours

次要结局

  • Incretin hormones(Each 30 minutes, up to 510 minutes, from 8h30 am to 5h00 pm)
  • Side effects of the supplement(60, 180, 300, 420 and 540 minutes after the beginning of the test)
  • Mean plasma glucose(9 hours (over study period))
  • Percentage of time with plasma glucose concentration a. >8.0 mmol/L, b. >10.0 mmol/L, c. >11.0 mmol/L, and d. <4.0 mmol/L(9 hours (over study period))
  • Plasma insulin area under the curve(3 hours)
  • Post-meal peak plasma glucose(3 hours after each meal)
  • Positive incremental area under the curve for post-prandial glucose and insulin excursions(3 hours)

研究者

发起方
Institut de Recherches Cliniques de Montreal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rémi Rabasa-Lhoret

Associate Professor of Medicine

Institut de Recherches Cliniques de Montreal

研究点 (1)

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