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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Rhode Island Hospital
Study ID
NCT05723445
Status
Recruiting
Apply to this trial

Conditions

  • Cystic Fibrosis
  • Cystic Fibrosis With Intestinal Manifestations
  • Cystic Fibrosis-related Diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Low Glycemic Load Diet — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Aug 2025
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Low Glycemic Load Diet
    Feeding study with dietary composition (approximately) 50% fat, 20% protein, 30% carbohydrate.

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Melissa S Putman, MD, MSc
[email protected]
617-355-7476
Rhode Island HospitalProvidenceRhode Island02903
Kevin J Scully, MB BCh BAO
[email protected]
401-444-5504

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By research site
Boston Children's Hospital· Boston, MARhode Island Hospital· Providence, RI

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