Cystic Fibrosis-related DiabetesSOFINCT02810691
The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis
A study testing Soluble fiber supplementation in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- What is being tested?
- Soluble fiber supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
About this study
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.
Read the detailed description
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.
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Being tested
- Soluble fiber supplementation, Placebo (for fiber supplementation)
- Keywords
- Diabetes, Fiber, Supplementation, Soluble fiber, Post-prandial blood glucose, Nutrition
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soluble fiber supplementationDietary supplement
Two different doses of psyllium powder will be diluted in 250 ml of orange-flavored water and drink in 5 minutes before breakfast.
Placebo (for fiber supplementation)Dietary supplement
Placebo will consist of 250 ml of orange-flavored water to be drink in 5 minutes before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Soluble fiber, dose #1 | Active comparator | Soluble fiber supplementation with dose #1 (smaller dose) of psyllium fiber. Receives: Dietary Supplement: Soluble fiber supplementation |
| Soluble fiber, dose #2 | Active comparator | Soluble fiber supplementation with dose #2 (bigger dose) of psyllium fiber. Receives: Dietary Supplement: Soluble fiber supplementation |
| Placebo | Placebo comparator | A 250 ml placebo solution of orange-flavored water will be drink at breakfast. Receives: Dietary Supplement: Placebo (for fiber supplementation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose area under the curve
Measured: 3 hours
Secondary outcomes (7)
Plasma insulin area under the curve
Measured: 3 hours
Incretin hormones
Glucagon-like peptide, gastric inhibitory polypeptide
Measured: Each 30 minutes, up to 510 minutes, from 8h30 am to 5h00 pm
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.
Measured: 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
Measured: 3 hours
Mean plasma glucose
Measured: 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
Measured: 9 hours (over study period)
Post-meal peak plasma glucose
For the breakfast and lunch
Measured: 3 hours after each meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cystic Fibrosis Foundation, Université de Montréal
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Rémi Rabasa-Lhoret, MD,PhD, Principal investigator, IRCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02810691
- Sponsor's protocol ID
- SOFI
- Acronym
- SOFI
- Status last verified
- Jul 2018
- First submitted
- 14 Jun 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02810691
- Acronym / sponsor ID
- SOFI / SOFI
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Keywords
- Diabetes, Fiber, Supplementation, Soluble fiber, Post-prandial blood glucose, Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Collaborators
- Canadian Cystic Fibrosis Foundation, Université de Montréal
- Study start
- Jul 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Soluble fiber, dose #1 | Active comparator | Dietary Supplement: Soluble fiber supplementationSoluble fiber supplementation with dose #1 (smaller dose) of psyllium fiber. |
| Soluble fiber, dose #2 | Active comparator | Dietary Supplement: Soluble fiber supplementationSoluble fiber supplementation with dose #2 (bigger dose) of psyllium fiber. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo (for fiber supplementation)A 250 ml placebo solution of orange-flavored water will be drink at breakfast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soluble fiber supplementationTwo different doses of psyllium powder will be diluted in 250 ml of orange-flavored water and drink in 5 minutes before breakfast. | Dietary supplement | Soluble fiber, dose #1, Soluble fiber, dose #2 |
| Placebo (for fiber supplementation)Placebo will consist of 250 ml of orange-flavored water to be drink in 5 minutes before breakfast. | Dietary supplement | Placebo |
Primary outcome
Plasma glucose area under the curve
Time frame: 3 hours
7 secondary outcomes
Plasma insulin area under the curve
Time frame: 3 hours
Incretin hormones
Time frame: Each 30 minutes, up to 510 minutes, from 8h30 am to 5h00 pm
Side effects of the supplement
Time frame: 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
Time frame: 3 hours
Mean plasma glucose
Time frame: 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
Time frame: 9 hours (over study period)
Post-meal peak plasma glucose
Time frame: 3 hours after each meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rémi Rabasa-Lhoret, MD,PhD principal investigator
IRCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soluble fiber supplementation in people with Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma glucose area under the curve (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.