No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Rhode Island Hospital · Other
Who this trial is looking for
This trial is looking for adults with cystic fibrosis-related diabetes. Participants will follow a low glycemic load diet while their blood sugar levels and overall health are monitored.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have a genetic diagnosis of cystic fibrosis
I have pancreatic insufficiency and need enzyme replacement
I have been diagnosed with cystic fibrosis-related diabetes
You may not be able to join if
I have a FEV1 below 50% from my last lung test
My BMI is below 18 kg/m2
I am currently receiving enteral nutrition through a feeding tube
I am pregnant or plan to become pregnant in the next 3 months
I am currently using IV antibiotics for cystic fibrosis
I have changed my treatment with a CFTR modulator in the last 3 months
I am already following a low glycemic load diet
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 condit…
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.
Trial Locations
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Status
Eligibility Criteria
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…
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)
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