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New treatment option for Cystic Fibrosis
Official title The Effects of a Low Glycemic Load Diet on Dysglycemia and Body Composition in Adults With Cystic Fibrosis-Related Diabetes
ClinicalTrials.gov ID: NCT05723445
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.