Cystic FibrosisNCT04519853
A Pilot Study of a Low Glycemic Load Diet in Adults With Cystic Fibrosis
A study testing Low Glycemic Load Diet in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This pilot study will evaluate the safety and tolerability of a low glycemic load dietary intervention in adult patients with cystic fibrosis (CF) in a rigorous feeding study. Specific emphasis will be placed on changes in weight, body composition, and glycemic measures obtained via continuous glucose monitor (CGM)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis With Intestinal Manifestations
- What is being tested?
- Low Glycemic Load Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 1 Jul 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CF
- Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
- Oral glucose tolerance test within the past three years showing impaired glucose tolerance (2-hour glucose ≥140 mg/dL) or indeterminate glycemia (1-hour glucose ≥200), HbA1c 5.7-6.4% in the past one year, and/or or documented random glucose ≥200 in the past one year
- BMI 21-25 kg/m2
- 18 years and above
Who cannot join
- Current use of insulin
- Most recent HbA1c ≥6.5%
- History of solid organ transplant or currently listed for solid organ transplant
- FEV1 <50% predicted on most recent pulmonary function testing
- Currently receiving enteral nutrition support
- Current or anticipated pregnancy in the next 1 year
Show all 9Show fewer
- Hospitalization for CF exacerbation within 1 month of enrollment
- Started or stopped treatment with Trikafta or other CFTR modulator within 3 months of enrollment
- Currently adhering to a low glycemic index or other carbohydrate restricted diet
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study to Test the Safety and Tolerability of a Low Glycemic Load Dietary Intervention in Adults With Cystic Fibrosis
This pilot study will evaluate the safety and tolerability of a low glycemic load dietary intervention in adult patients with cystic fibrosis (CF) in a rigorous feeding study. Specific emphasis will be placed on changes in weight, body composition, and glycemic measures obtained via continuous glucose monitor (CGM) usage.
Read the detailed description
Non-pulmonary complications of cystic fibrosis (CF) are becoming increasingly prevalent with the changing landscape of CF care. CF related diabetes mellitus (CFRD) and CF related gastrointestinal (GI) complications have significant effects on morbidity and mortality. Treatment options are limited to insulin therapy for CFRD and symptom control for most GI complications.
BMI is a well-established marker of morbidity and mortality in patients with CF. Many patients consume a high carbohydrate intake to meet their increase caloric needs, potentially leading to complications including post-prandial hyperglycemia, increased inflammation, and abnormal GI motility. Dietary recommendations for children and adults with CF are limited and based entirely on consensus and expert opinion. As patients with CF live longer with highly effective modulator therapy, it is important to understand the effects of dietary composition on short and long-term endocrine, GI, and pulmonary outcomes.
The investigators will conduct a prospective, open-label pilot study in adults with CF and impaired glucose tolerance or indeterminate glycemia to establish the safety and tolerability of a low glycemic load (LGL) diet. Subjects will initially follow their standard diet for a 2-week run-in period, then transition to a LGL diet provided by a food delivery service for the remaining 8 weeks. The investigators will also investigate potential short-term outcomes of dietary carbohydrate manipulation, including glycemic variability measured by continuous glucose monitor (CGM), body composition via DXA, GI symptoms, and quality of life measures.
The investigators hypothesize that a diet lower in carbohydrate content will be safe, tolerable, and associated with weight maintenance or gain, and that a LGL diet will result in decreased glycemic variability via CGM, improved GI symptoms, increased lean to fat mass ratio, and improved quality of life measures over an 8-week period.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis With Intestinal Manifestations
- Being tested
- Low Glycemic Load Diet
- Keywords
- Cystic Fibrosis Related Diabetes, Low Glycemic Load, Continuous Glucose Monitoring
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Glycemic Load DietBehavioural
Food delivery service will provide a low glycemic load diet for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low Glycemic Load Diet | Experimental | Feeding study with dietary composition (approximately) 50% fat, 30% carbohydrate, 20% protein. Receives: Behavioral: Low Glycemic Load Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from baseline and 10 weeks
Anthropometric measure
Measured: Baseline and 10 weeks
Change in percent time <54 mg/dL
Continuous glucose monitoring
Measured: Baseline and 10 weeks
Patient reported tolerability of dietary intervention, Likert scale
Single Likert scale question of overall diet tolerability, ranging from 1 (intolerable) to 10 (completely tolerable)
Measured: Single measurement at 10 weeks after diet completion
Secondary outcomes (19)
Change in percent time >140 mg/dL
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in CGM average glucose
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in CGM glucose management indicator (GMI)
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in CGM standard deviation (SD)
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in CGM coefficient of variation (CV)
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in percent time less than 50 mg/dL on CGM
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in percent time less than 70 mg/dL on CGM
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in percent time 70-180 mg/dL on CGM
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in percent time greater than 180 mg/dL on CGM
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Change in percent time greater than >250 mg/dL on CGM
Continuous glucose monitoring
Measured: Baseline to 10 weeks
Number of episodes of symptomatic hypoglycemia
Survey
Measured: Baseline and 10 weeks
Change in lean and fat mass
DXA body composition measures
Measured: Baseline and 10 weeks
Change in Patient Assessment of Constipation (PAC) questionnaire score
Likert scale questionnaire with 12 items, each item scored 0-4, total score ranging from 0-48 with higher scores related to worse outcomes
Measured: Baseline and 10 weeks
Change in Patient Assessment of Gastrointestinal Symptom (PAGI-SYM) questionnaire score
Likert scale questionnaire with 20 items, each item scored 0-5, total score ranging from 0-100 with higher scores related to worse outcomes
Measured: Baseline and 10 weeks
Change in Modified Activity Questionnaire (MAQ) score
Questionnaire, units of total hours of exercise over past 12 months, no min or max scores, higher value related to better outcome
Measured: Baseline and 10 weeks
Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) score
Likert scale questionnaire, 50 items, each scored 0-4, total score ranging from 0-100 with higher value reflecting better outcome
Measured: Baseline and 10 weeks
Change in erythrocyte sedimentation rate (ESR)
Laboratory test, measured in mm/hr
Measured: Baseline and 10 weeks
Change in c-reactive protein (CRP)
Laboratory test, measured in mg/L
Measured: Baseline and 10 weeks
Change in intestinal fatty acid binding protein (I-FABP)
Laboratory test, measured in ng/mL
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start25 Oct 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single dietary treatment arm with run-in period as a control
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Putman, Boston Children's Hospital
- Investigators
- Melissa S Putman, MD,MS, Principal investigator, Boston Children's Hospital; Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519853
- Sponsor's protocol ID
- P00034904
- Status last verified
- Aug 2023
- First submitted
- 7 Jul 2020
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD data with other researchers.
Publications
Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available.
PubMed 21115772Gabel ME, Galante GJ, Freedman SD. Gastrointestinal and Hepatobiliary Disease in Cystic Fibrosis. Semin Respir Crit Care Med. 2019 Dec;40(6):825-841. doi: 10.1055/s-0039-1697591. Epub 2019 Oct 28.
PubMed 31659728Prentice BJ, Ooi CY, Strachan RE, Hameed S, Ebrahimkhani S, Waters SA, Verge CF, Widger J. Early glucose abnormalities are associated with pulmonary inflammation in young children with cystic fibrosis. J Cyst Fibros. 2019 Nov;18(6):869-873. doi: 10.1016/j.jcf.2019.03.010. Epub 2019 Apr 26.
PubMed 31036487Brennan AL, Gyi KM, Wood DM, Johnson J, Holliman R, Baines DL, Philips BJ, Geddes DM, Hodson ME, Baker EH. Airway glucose concentrations and effect on growth of respiratory pathogens in cystic fibrosis. J Cyst Fibros. 2007 Apr;6(2):101-9. doi: 10.1016/j.jcf.2006.03.009. Epub 2006 Jul 17.
PubMed 16844431Balzer BW, Graham CL, Craig ME, Selvadurai H, Donaghue KC, Brand-Miller JC, Steinbeck KS. Low glycaemic index dietary interventions in youth with cystic fibrosis: a systematic review and discussion of the clinical implications. Nutrients. 2012 Apr;4(4):286-96. doi: 10.3390/nu4040286. Epub 2012 Apr 18.
PubMed 22606371
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Test the Safety and Tolerability of a Low Glycemic Load Dietary Intervention in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT04519853
- Acronym / sponsor ID
- P00034904
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis With Intestinal Manifestations
- Keywords
- Cystic Fibrosis Related Diabetes, Low Glycemic Load, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 20 Aug 2020 (actual)
- 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.
This pilot study will evaluate the safety and tolerability of a low glycemic load dietary intervention in adult patients with cystic fibrosis (CF) in a rigorous feeding study. Specific emphasis will be placed on changes in weight, body composition, and glycemic measures obtained via continuous glucose monitor (CGM) usage.
Detailed description
Non-pulmonary complications of cystic fibrosis (CF) are becoming increasingly prevalent with the changing landscape of CF care. CF related diabetes mellitus (CFRD) and CF related gastrointestinal (GI) complications have significant effects on morbidity and mortality. Treatment options are limited to insulin therapy for CFRD and symptom control for most GI complications.
BMI is a well-established marker of morbidity and mortality in patients with CF. Many patients consume a high carbohydrate intake to meet their increase caloric needs, potentially leading to complications including post-prandial hyperglycemia, increased inflammation, and abnormal GI motility. Dietary recommendations for children and adults with CF are limited and based entirely on consensus and expert opinion. As patients with CF live longer with highly effective modulator therapy, it is important to understand the effects of dietary composition on short and long-term endocrine, GI, and pulmonary outcomes.
The investigators will conduct a prospective, open-label pilot study in adults with CF and impaired glucose tolerance or indeterminate glycemia to establish the safety and tolerability of a low glycemic load (LGL) diet. Subjects will initially follow their standard diet for a 2-week run-in period, then transition to a LGL diet provided by a food delivery service for the remaining 8 weeks. The investigators will also investigate potential short-term outcomes of dietary carbohydrate manipulation, including glycemic variability measured by continuous glucose monitor (CGM), body composition via DXA, GI symptoms, and quality of life measures.
The investigators hypothesize that a diet lower in carbohydrate content will be safe, tolerable, and associated with weight maintenance or gain, and that a LGL diet will result in decreased glycemic variability via CGM, improved GI symptoms, increased lean to fat mass ratio, and improved quality of life measures over an 8-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single dietary treatment arm with run-in period as a control
| Arm | Type | Receives |
|---|---|---|
| Low Glycemic Load Diet | Experimental | Behavioral: Low Glycemic Load DietFeeding study with dietary composition (approximately) 50% fat, 30% carbohydrate, 20% protein. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of CF
- Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
- Oral glucose tolerance test within the past three years showing impaired glucose tolerance (2-hour glucose ≥140 mg/dL) or indeterminate glycemia (1-hour glucose ≥200), HbA1c 5.7-6.4% in the past one year, and/or or documented random glucose ≥200 in the past one year
- BMI 21-25 kg/m2
- 18 years and above
Key exclusion criteria (9 listed)
- Current use of insulin
- Most recent HbA1c ≥6.5%
- History of solid organ transplant or currently listed for solid organ transplant
- FEV1 <50% predicted on most recent pulmonary function testing
- Currently receiving enteral nutrition support
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 |
|---|---|---|
| Low Glycemic Load DietFood delivery service will provide a low glycemic load diet for 8 weeks | Behavioural | Low Glycemic Load Diet |
Primary outcome
Change in weight from baseline and 10 weeks
Time frame: Baseline and 10 weeks
Anthropometric measure
Change in percent time <54 mg/dL
Time frame: Baseline and 10 weeks
Continuous glucose monitoring
Patient reported tolerability of dietary intervention, Likert scale
Time frame: Single measurement at 10 weeks after diet completion
Single Likert scale question of overall diet tolerability, ranging from 1 (intolerable) to 10 (completely tolerable)
19 secondary outcomes
Change in percent time >140 mg/dL
Time frame: Baseline to 10 weeks
Change in CGM average glucose
Time frame: Baseline to 10 weeks
Change in CGM glucose management indicator (GMI)
Time frame: Baseline to 10 weeks
Change in CGM standard deviation (SD)
Time frame: Baseline to 10 weeks
Change in CGM coefficient of variation (CV)
Time frame: Baseline to 10 weeks
Change in percent time less than 50 mg/dL on CGM
Time frame: Baseline to 10 weeks
Change in percent time less than 70 mg/dL on CGM
Time frame: Baseline to 10 weeks
Change in percent time 70-180 mg/dL on CGM
Time frame: Baseline to 10 weeks
Change in percent time greater than 180 mg/dL on CGM
Time frame: Baseline to 10 weeks
Change in percent time greater than >250 mg/dL on CGM
Time frame: Baseline to 10 weeks
Number of episodes of symptomatic hypoglycemia
Time frame: Baseline and 10 weeks
Change in lean and fat mass
Time frame: Baseline and 10 weeks
Change in Patient Assessment of Constipation (PAC) questionnaire score
Time frame: Baseline and 10 weeks
Change in Patient Assessment of Gastrointestinal Symptom (PAGI-SYM) questionnaire score
Time frame: Baseline and 10 weeks
Change in Modified Activity Questionnaire (MAQ) score
Time frame: Baseline and 10 weeks
Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) score
Time frame: Baseline and 10 weeks
Change in erythrocyte sedimentation rate (ESR)
Time frame: Baseline and 10 weeks
Change in c-reactive protein (CRP)
Time frame: Baseline and 10 weeks
Change in intestinal fatty acid binding protein (I-FABP)
Time frame: Baseline and 10 weeks
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 14 Aug 2023.
- Background: PubMed 21115772Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available.
- Background: PubMed 31659728Gabel ME, Galante GJ, Freedman SD. Gastrointestinal and Hepatobiliary Disease in Cystic Fibrosis. Semin Respir Crit Care Med. 2019 Dec;40(6):825-841. doi: 10.1055/s-0039-1697591. Epub 2019 Oct 28.
- Background: PubMed 31036487Prentice BJ, Ooi CY, Strachan RE, Hameed S, Ebrahimkhani S, Waters SA, Verge CF, Widger J. Early glucose abnormalities are associated with pulmonary inflammation in young children with cystic fibrosis. J Cyst Fibros. 2019 Nov;18(6):869-873. doi: 10.1016/j.jcf.2019.03.010. Epub 2019 Apr 26.
- Background: PubMed 16844431Brennan AL, Gyi KM, Wood DM, Johnson J, Holliman R, Baines DL, Philips BJ, Geddes DM, Hodson ME, Baker EH. Airway glucose concentrations and effect on growth of respiratory pathogens in cystic fibrosis. J Cyst Fibros. 2007 Apr;6(2):101-9. doi: 10.1016/j.jcf.2006.03.009. Epub 2006 Jul 17.
- Background: PubMed 22606371Balzer BW, Graham CL, Craig ME, Selvadurai H, Donaghue KC, Brand-Miller JC, Steinbeck KS. Low glycaemic index dietary interventions in youth with cystic fibrosis: a systematic review and discussion of the clinical implications. Nutrients. 2012 Apr;4(4):286-96. doi: 10.3390/nu4040286. Epub 2012 Apr 18.
- Individual participant dataSharing planned: No. There is no plan to share IPD data with other researchers.
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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.
Melissa S Putman, MD,MS principal investigator
Boston Children's Hospital; Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Glycemic Load Diet in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by Boston Children's Hospital at 1 site in United States.
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 5 inclusion and 9 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 14 Aug 2023. 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 United States. 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. 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?
Change in weight from baseline and 10 weeks (time frame: Baseline and 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519853, which also lists 5 linked publications.
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 14 Aug 2023.