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Cystic FibrosisDINENCT05723445

The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes

A study testing Low Glycemic Load Diet in people with Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by Rhode Island Hospital at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related diabetes (CFRD). Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Low Glycemic Load Diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesUnited States
Study dates
1 Sep 2023to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 18 years and above
  • Genetically confirmed diagnosis of CF
  • Diagnosis of pancreatic insufficiency, requiring pancreatic enzyme replacement
  • Criteria for CFRD:
  • A.) Most recent OGTT 2-hour glucose >200 mg/dL within the past two years, and/or; B.) HbA1c >6.5% in the past two years, and/or; C.) Current use of insulin

Who cannot join

  • FEV1 <50% predicted on most recent pulmonary function testing
  • BMI <18 kg/m2
  • Currently receiving enteral nutrition support via GT feeds
  • Pregnancy, plan to become pregnant in the next 3-months, or sexually active without use of contraception
  • Use of IV antibiotics or systemic supraphysiologic glucocorticoids for CF exacerbation within 1 month
  • Started or stopped treatment with a CFTR modulator within 3 months of enrollment
  • Currently adhering to an LGL or other carbohydrate-restricted diet (carbohydrate intake <30% of total daily caloric intake)

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kevin J Scully, MB BCh BAO contact

401-444-5504

kevin_scully@brown.edu

Melissa S Putman, MD, MSc contact

617-355-7476

melissa.putman@childrens.harvard.edu

United States2 sites, 2 recruiting

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

    Melissa S Putman, MD, MSc, 617-355-7476, melissa.putman@childrens.harvard.edu

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Kevin J Scully, MB BCh BAO, 401-444-5504, kevin_scully@brown.edu

    Recruiting

Other trials in United States

About this study

This study will evalute the effect of a low glycemic load (LGL diet on dysglycemia, insulin requirements, DXA-derived body composition, gastrointestinal symptoms and quality of life measures in adults with cystic fibrosis-related diabetes (CFRD). We will use continuous glucose monitors (CGM) to assess the LGL diet both in a controlled setting (via a meal delivery company) and in free-living conditions.

Read the detailed description

Maintenance of a healthy body mass index (BMI) is a well-established marker of improved morbidity and mortality in patients with cystic fibrosis (CF). To achieve and maintain adequate weight, patients with CF are encouraged to consume a caloric intake of 120-150% of the dietary reference intake (DRI) for the typical healthy adult. However, dietary recommendations for children and adults with CF are based entirely on consensus and expert opinion. High carbohydrate intake is typical for patients with CF, but this may lead to multiple complications including post-prandial hyperglycemia, increased inflammation, and abnormal GI motility and may predispose to obesity and metabolic syndrome. Dietary changes are a commonly used treatment approach for CF-related diabetes (CFRD), despite the fact that there are no data establishing whether dietary interventions are helpful in preventing and/or treating CFRD. Particularly as patients with CF live longer with highly effective modulator therapy and as the prevalence of cardiovascular and metabolic disease increases in this population, it is crucial to understand the effects of dietary composition on short and long-term endocrine, GI, and pulmonary outcomes.

In patients with both type 1 and type 2 diabetes mellitus, a low glycemic load (LGL) diet has been shown to improve glycemic variability, A1c level, insulin sensitivity, and quality of life without increasing hypoglycemic events. Significant glycemic variability is associated with increased markers of inflammation in adolescents with T1DM, possibly serving as a mechanistic link to the development of cardiovascular disease. Particularly as rates of obesity and cardiovascular disease continue to increase, this diet may be particularly useful in patients with CF, altered glucose homeostasis, and/or obesity. There are currently no prospective studies evaluating the impact of diet quality on glycemic control and body composition in patients with CF. The gold standard approach for assessing the safety and efficacy of dietary interventions is a food delivery study.

The investigators will conduct a prospective, open-label study in adults with CFRD to determine the effects of an LGL diet on dysglycemia and body composition. Participants will initially follow their standard diet for a 10-day run-in period. They will then transition to an LGL diet provided by a meal delivery company for 8 weeks. During this period, they will wear a continuous glucose monitor (CGM) for 2 10-day periods. Finally, participants will adhere to an LGL diet under free-living conditions with close nutritionist follow-up for a period of 4 months. Serum studies, DXA-body composition, anthropometric data, GI symptoms and quality of life measures will be obtained at baseline, after the meal-delivery phase and at study completion.

The investigators hypothesize that an LGL diet will result in improved CGM-derived measures of hyperglycemia, a decrease in insulin requirements, and reductions in fat-mass index on DXA analysis in adults with CFRD over an 8-week period during a meal delivery period. Furthermore, they hypothesize that these changes will be sustainable under free-living conditions during a 4-month period.

Being tested
Low Glycemic Load Diet
Keywords
Cystic Fibrosis-Related Diabetes, Low Glycemic Load, Continuous Glucose Monitoring, Body Composition
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, followed by a 4-month period of self-adherence to a low glycemic load diet with close nutritionist follow up

Study groups in NCT05723445
Study groupRoleWhat they receive
Low Glycemic Load DietExperimentalFeeding study with dietary composition (approximately) 50% fat, 20% protein, 30% carbohydrate.
Receives: Behavioral: Low Glycemic Load Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in percent time in target range 70-180 mg/dL

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

Secondary outcomes (27)

  1. Change in CGM average glucose (AG) mg/dL

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

  2. Change in percent time >180 mg/dL

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

  3. Change in percent time >250 mg/dL

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

  4. Change in CGM standard deviation (SD)

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

  5. Change in CGM coefficient of variation (CV)

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

  6. Change in percent time <70 mg/dL

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

  7. Change in percent time <54 mg/dL

    Continuous glucose monitoring

    Measured: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)

  8. Change in number of episodes of symptomatic hypoglycemia (average per week)

    Weekly emailed survey

    Measured: Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26))

  9. Change in total daily dose of insulin (TDD)

    Weekly emailed survey

    Measured: Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26)

  10. Change in body mass index (BMI, kg/m2)

    Every other week emailed survey

    Measured: Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26)

  11. Change in weight (kg)

    Every other week emailed survey

    Measured: Baseline (weeks 1-2), visit 2 (post-meal delivery phase, weeks 2-10), visit 3 (post-free living conditions phase, weeks 11-26)

  12. Change fat-mass index (FMI, fat mass kg/ height m^2)

    DXA body composition measures

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  13. Change in percent body fat (%)

    DXA body composition measures

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  14. Change in appendicular lean mass index (ALMI, lean mass kg/ height m^2)

    DXA body composition measures

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  15. Change in Patient Assessment of Constipation (PAC) questionnaire score

    Likert scale questionnaire with 12 items, each scored 0-4, total score ranging from 0-48 with higher scores related to worse outcomes

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  16. Change in Patient Assessment of Gastrointestinal Symptoms (PAGI-Sym) questionnaire score

    Likert scale questionnaire with 20 items, each scored 0-5, total score ranging from 0-100 with higher scores related to worse outcomes

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  17. Change in Cystic Fibrosis Questionnaire Revised (CFQ-R) score

    Likert scale questionnaire with 50 items, each scored 0-4, total score ranging from 0-100 with higher scores reflecting better outcomes

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  18. Change in Diet Tolerability Questionnaire

    Likert scale questionnaire with 5 items, each scored 0-10, total score ranging from 0-50 with higher scores reflecting better diet tolerability

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  19. Change in Bristol stool chart data

    Chart depicting 7 types of stool patterns, ranging from constipation to diarrhea

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  20. Change in erythrocyte sedimentation rate (ESR)

    Laboratory test, measured in mm/hr

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  21. Change in c-reactive protein (CRP)

    Laboratory test, measured in mg/L

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  22. Change in hemoglobin A1c

    Laboratory test, measured in %

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  23. Change in total cholesterol

    Laboratory test, measured in mg/dL

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  24. Change in high-density lipoprotein (HDL)

    Laboratory test, measured in mg/dL

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  25. Change in low-density lipoprotein (LDL)

    Laboratory test, measured in mg/dL

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  26. Change in triglyceride level

    Laboratory test, measured in mg/dL

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

  27. Change in intestinal fatty acid binding protein (I-FABP)

    Laboratory test, measured in ng/mL

    Measured: Baseline (week 1), visit 2 (post-meal delivery phase, week10), visit 3 (post-free living conditions phase, week 26)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2023
  2. Study start1 Sep 2023
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

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
Sequential
Model description
Single dietary treatment with a meal-delivery phase and free-living conditions phase, as well as a run-in period as a control
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05723445
Sponsor's protocol ID
1943156-3
Acronym
DINE
Status last verified
Aug 2025
First submitted
16 Jan 2023
Last updated
22 Aug 2025
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

  • Culhane S, George C, Pearo B, Spoede E. Malnutrition in cystic fibrosis: a review. Nutr Clin Pract. 2013 Dec;28(6):676-83. doi: 10.1177/0884533613507086. Epub 2013 Oct 29.

    PubMed 24170579

  • 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 21115772

  • Gaskin KJ. Nutritional care in children with cystic fibrosis: are our patients becoming better? Eur J Clin Nutr. 2013 May;67(5):558-64. doi: 10.1038/ejcn.2013.20. Epub 2013 Mar 6.

    PubMed 23462946

  • Thomas D, Elliott EJ. Low glycaemic index, or low glycaemic load, diets for diabetes mellitus. Cochrane Database Syst Rev. 2009 Jan 21;2009(1):CD006296. doi: 10.1002/14651858.CD006296.pub2.

    PubMed 19160276

  • Hoffman RP, Dye AS, Huang H, Bauer JA. Glycemic variability predicts inflammation in adolescents with type 1 diabetes. J Pediatr Endocrinol Metab. 2016 Oct 1;29(10):1129-1133. doi: 10.1515/jpem-2016-0139.

    PubMed 27658133

  • Panagopoulou P, Fotoulaki M, Nikolaou A, Nousia-Arvanitakis S. Prevalence of malnutrition and obesity among cystic fibrosis patients. Pediatr Int. 2014 Feb;56(1):89-94. doi: 10.1111/ped.12214.

    PubMed 24003895

  • Stephenson AL, Mannik LA, Walsh S, Brotherwood M, Robert R, Darling PB, Nisenbaum R, Moerman J, Stanojevic S. Longitudinal trends in nutritional status and the relation between lung function and BMI in cystic fibrosis: a population-based cohort study. Am J Clin Nutr. 2013 Apr;97(4):872-7. doi: 10.3945/ajcn.112.051409. Epub 2013 Feb 6.

    PubMed 23388659

  • Harindhanavudhi T, Wang Q, Dunitz J, Moran A, Moheet A. Prevalence and factors associated with overweight and obesity in adults with cystic fibrosis: A single-center analysis. J Cyst Fibros. 2020 Jan;19(1):139-145. doi: 10.1016/j.jcf.2019.10.004. Epub 2019 Nov 11.

    PubMed 31727452

  • Lennerz BS, Barton A, Bernstein RK, Dikeman RD, Diulus C, Hallberg S, Rhodes ET, Ebbeling CB, Westman EC, Yancy WS Jr, Ludwig DS. Management of Type 1 Diabetes With a Very Low-Carbohydrate Diet. Pediatrics. 2018 Jun;141(6):e20173349. doi: 10.1542/peds.2017-3349. Epub 2018 May 7.

    PubMed 29735574

  • Norris AW, Ode KL, Merjaneh L, Sanda S, Yi Y, Sun X, Engelhardt JF, Hull RL. Survival in a bad neighborhood: pancreatic islets in cystic fibrosis. J Endocrinol. 2019 Apr;241(1):R35-R50. doi: 10.1530/JOE-18-0468.

    PubMed 30759072

  • Prentice 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 31036487

  • Ode KL, Frohnert B, Laguna T, Phillips J, Holme B, Regelmann W, Thomas W, Moran A. Oral glucose tolerance testing in children with cystic fibrosis. Pediatr Diabetes. 2010 Nov;11(7):487-92. doi: 10.1111/j.1399-5448.2009.00632.x.

    PubMed 20202149

  • Bellissimo MP, Zhang I, Ivie EA, Tran PH, Tangpricha V, Hunt WR, Stecenko AA, Ziegler TR, Alvarez JA. Visceral adipose tissue is associated with poor diet quality and higher fasting glucose in adults with cystic fibrosis. J Cyst Fibros. 2019 May;18(3):430-435. doi: 10.1016/j.jcf.2019.01.002. Epub 2019 Jan 18.

    PubMed 30665857

  • Scully KJ, Sherwood JS, Martin K, Ruazol M, Marchetti P, Larkin M, Zheng H, Sawicki GS, Uluer A, Neuringer I, Yonker LM, Sicilian L, Wexler DJ, Putman MS. Continuous Glucose Monitoring and HbA1c in Cystic Fibrosis: Clinical Correlations and Implications for CFRD Diagnosis. J Clin Endocrinol Metab. 2022 Mar 24;107(4):e1444-e1454. doi: 10.1210/clinem/dgab857.

    PubMed 34850006

  • Scully KJ, Jay LT, Freedman S, Sawicki GS, Uluer A, Finkelstein JS, Putman MS. The Relationship between Body Composition, Dietary Intake, Physical Activity, and Pulmonary Status in Adolescents and Adults with Cystic Fibrosis. Nutrients. 2022 Jan 12;14(2):310. doi: 10.3390/nu14020310.

    PubMed 35057491

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 Rhode Island Hospital at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kevin J Scully, MB BCh BAO (401-444-5504, kevin_scully@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percent time in target range 70-180 mg/dL (time frame: Baseline, post-meal delivery phase (8 weeks), post-free-living conditions phase (4 months)). 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 NCT05723445, which also lists 21 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 22 Aug 2025.

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