Cystic Fibrosis Clinical Trial
— SOFIOfficial title:
The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis
NCT number | NCT02810691 |
Other study ID # | SOFI |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | April 2018 |
Verified date | July 2018 |
Source | Institut de Recherches Cliniques de Montreal |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | April 2018 |
Est. primary completion date | April 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Institut de recherches cliniques de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Institut de Recherches Cliniques de Montreal | Canadian Cystic Fibrosis Foundation, Université de Montréal |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma glucose area under the curve | 3 hours | ||
Secondary | Plasma insulin area under the curve | 3 hours | ||
Secondary | Incretin hormones | Glucagon-like peptide, gastric inhibitory polypeptide | Each 30 minutes, up to 510 minutes, from 8h30 am to 5h00 pm | |
Secondary | Side effects of the supplement | It will be measure with gastro-intestinal symptoms visual analog scale. There will be 3 continuous scales for gastrointestinal symptoms and 5 continuous scales to evaluate the satiety. Each scale will measure 100 mm. The score is the distance measured in millimeters from the "no pain" anchor to the participant's mark. | 60, 180, 300, 420 and 540 minutes after the beginning of the test | |
Secondary | Positive incremental area under the curve for post-prandial glucose and insulin excursions | 3 hours | ||
Secondary | Mean plasma glucose | 9 hours (over study period) | ||
Secondary | 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) | ||
Secondary | Post-meal peak plasma glucose | For the breakfast and lunch | 3 hours after each meal |
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