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

RECRUITINGN/ASponsored by Rhode Island Hospital
Actively Recruiting
PhaseN/A
SponsorRhode Island Hospital
Started2023-09-01
Est. completion2026-07-01
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
Locations2 sites

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). 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.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Conditions4

Cystic FibrosisCystic Fibrosis With Intestinal ManifestationsCystic Fibrosis-related DiabetesDiabetes

Locations2 sites

Massachusetts

1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
Melissa S Putman, MD, MSc617-355-7476melissa.putman@childrens.harvard.edu

Rhode Island

1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
Kevin J Scully, MB BCh BAO401-444-5504kevin_scully@brown.edu

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