Cystic Fibrosis study: Low Glycemic Load Diet
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
- The study wants to find out if eating foods that cause a slow rise in blood sugar can improve blood sugar control, reduce insulin needs, and change body composition in people with cystic fibrosis‑related diabetes.
- Who it's for
- Adults who have cystic fibrosis and cystic fibrosis‑related diabetes, including those with intestinal problems.
- What's involved
- Participants will follow a low‑glycemic‑load diet. They will use continuous glucose monitors to track blood sugar during a controlled meal‑delivery period and while eating normally. They may also have body composition scans and answer questions about symptoms and quality of life.
- Time commitment
- The study lasts several weeks, with regular visits for monitoring, diet counseling, and tests, plus ongoing use of glucose monitors during the study period.
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 is enrolling
- 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, but 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?
This study is enrolling now at Boston, Massachusetts, United States; Providence, Rhode Island, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.