Scientists probe gut hormones to unlock diabetes mystery in cystic fibrosis
NCT ID NCT01851694
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aims to understand why many people with cystic fibrosis develop diabetes. Researchers will give two gut hormones, GLP-1 and GIP, to 45 adults with cystic fibrosis and measure how their pancreas releases insulin. The goal is to learn more about cystic fibrosis-related diabetes and find better ways to treat it in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GLP-1 and GIP (hormones that boost insulin)
- What this could lead to
- If successful, this research could point toward new treatment options for cystic fibrosis-related diabetes.
- What could go wrong
- This is an early-stage observational study with only 45 participants, so results may not apply to everyone. It aims to understand the disease, not test a treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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May 2013
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria, 2. Age greater than or equal to 18y on date of consent 3. Pancreatic insufficiency 4. Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia 5. For female subjects, negative urine pregnancy test at enrollment. Control Subjects: 1. No history of cystic fibrosis. 2. Age ≥ 18y on date of consent. 3. Recent OGTT consistent with NGT. 4. For female subjects, negative urine pregnancy test at enrollment. Exclusion Criteria: 1. Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia (fasting glucose greater than126 mg/dL) 2. History of clinically symptomatic pancreatitis within last year 3. Prior lung or liver transplant 4. Severe CF liver disease, as defined by portal hypertension 5. Fundoplication-related dumping syndrome 6. Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency) 7. Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to study procedures 8. Treatment with oral or intravenous corticosteroids within 6 weeks of study 9. Hemoglobin less than10g/dL, within 90 days of Visit 1 or at Screening 10. Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq/L on non-hemolyzed specimen 11. Inability to perform study specific procedures (MMTT, GPA) 12. Subjects, who in study team opinion, may be non-compliant with study procedures. Control Subjects who will be exposed to GIP only: 1. History of clinically symptomatic pancreatitis. 2. History of liver disease. 3. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject. 4. Hemoglobin \<10g/dL, within 90 days of GPA test or at Screening. 5. Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine \> 2x upper limit of normal (ULN) or potassium \> 5.5mEq/L on non-hemolyzed specimen. 6. Inability to perform study specific procedures (MMTT, GPA). 7. subjects, who in study team opinion, may be non-compliant with study procedures. 8. elevation of serum amylase or lipase \> 1.5x ULN within 90 days of GPA test.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Philadelphia and University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19060, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a simple questionnaire reveal why some cystic fibrosis patients skip physiotherapy?
- Glucose sensor may flag diabetes risk in cystic fibrosis
- Cystic fibrosis diabetes: do gut hormones and genes hold the key?
- Can a special lung scan catch cystic fibrosis damage earlier than standard tests?
- Can a pill replace the liquid? testing a new form of cystic fibrosis drug