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

NCT02810691 | Completed

• 1 other identifier: SOFI
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cystic Fibrosis-related Diabetes; Cystic Fibrosis

Keywords

Diabetes; Fiber; Supplementation; Soluble fiber; Post-prandial blood glucose; Nutrition

Outcome Measures

Primary Outcomes (1)

• Plasma glucose area under the curve

  3 hours

Secondary Outcomes (7)

• Plasma insulin area under the curve

  3 hours

• 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

• Positive incremental area under the curve for post-prandial glucose and insulin excursions

  3 hours

• Mean plasma glucose

  9 hours (over study period)

Study Arms (3)

Soluble fiber, dose #1

ACTIVE COMPARATOR

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

Dietary Supplement: Soluble fiber supplementation

Soluble fiber, dose #2

ACTIVE COMPARATOR

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

Dietary Supplement: Soluble fiber supplementation

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (for fiber supplementation)

Interventions

Soluble fiber supplementation DIETARY_SUPPLEMENT

Two different doses of psyllium powder will be diluted in 250 ml of orange-flavored water and drink in 5 minutes before breakfast.

Soluble fiber, dose #1; Soluble fiber, dose #2

Placebo (for fiber supplementation) DIETARY_SUPPLEMENT

Placebo will consist of 250 ml of orange-flavored water to be drink in 5 minutes before breakfast.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Canadian Cystic Fibrosis Foundation: collaborator
• Université de Montréal: collaborator

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

Location

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rémi Rabasa-Lhoret, MD,PhD

  IRCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 23, 2016
• Study Start: July 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)