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Scientists probe gut hormones to unlock diabetes mystery in cystic fibrosis

NCT ID NCT01851694

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Start date

May 2013

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Children's Hospital of Philadelphia and University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19060, United States

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