Cystic Fibrosis Trial, Recruiting NCT01851694 Sponsor: University of Pennsylvania Condition: Cystic Fibrosis
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Cystic Fibrosis Trial, Recruiting

NCT01851694
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For people with cystic fibrosis:

  • A confirmed diagnosis of cystic fibrosis, based on a sweat test or genetic (CFTR) mutation analysis following Cystic Fibrosis Foundation diagnostic standards
  • Age 18 or older at the time of signing consent
  • Pancreatic insufficiency (the pancreas does not produce enough digestive enzymes)
  • A recent oral glucose tolerance test (a sugar-drink blood test) showing a specific type of blood sugar problem — either borderline, mildly abnormal, or cystic fibrosis-related diabetes without high fasting blood sugar levels
  • For women: a negative urine pregnancy test at the time of enrolment

For healthy control participants (people without cystic fibrosis):

  • No history of cystic fibrosis
  • Age 18 or older at the time of signing consent
  • A recent oral glucose tolerance test showing normal blood sugar regulation
  • For women: a negative urine pregnancy test at the time of enrolment

Who may not be able to join:

For people with cystic fibrosis:

  • A diagnosis of a non-cystic-fibrosis type of diabetes (such as Type 1 diabetes), or cystic fibrosis-related diabetes with high fasting blood sugar levels (fasting glucose above 126 mg/dL)
  • A history of painful pancreatitis (inflammation of the pancreas) in the past year
  • A previous lung or liver transplant
  • Severe liver disease related to cystic fibrosis, specifically involving high blood pressure in the liver's portal vein
  • A condition called dumping syndrome related to a prior stomach surgery (fundoplication)
  • Other significant health conditions unrelated to cystic fibrosis, or conditions considered unstable by the investigating doctor (for example, a history of bleeding disorders or immune system problems)
  • An acute illness or a change in treatment (including antibiotics) within the 6 weeks before study procedures
  • Use of steroid tablets or intravenous steroids within 6 weeks before the study
  • A low haemoglobin (red blood cell protein) level below 10g/dL, measured within 90 days before the first visit or at screening
  • Abnormal kidney function within 90 days before the first visit or at screening, based on specific blood test results (confirm with trial site)
  • Being unable to complete the specific study procedures required (confirm with trial site)
  • Participants who, in the study team's opinion, may be unlikely to follow the study procedures

For healthy control participants (people without cystic fibrosis):

  • Any history of clinically symptomatic pancreatitis (painful pancreas inflammation)
  • Any history of liver disease
  • Any illness or condition that, in the investigator's opinion, could affect the study results or create additional risk
  • A low haemoglobin level below 10g/dL within 90 days before the relevant test or at screening
  • Abnormal kidney function within 90 days before the relevant test or at screening, based on specific blood test results (confirm with trial site)
  • Being unable to complete the specific study procedures required (confirm with trial site)
  • Participants who, in the study team's opinion, may be unlikely to follow the study procedures
  • Elevated levels of certain pancreatic enzymes (amylase or lipase) in the blood, above 1.5 times the upper limit of normal, within 90 days before the relevant test

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Michael R. Rickels, MD, MS, University of Pennsylvania

Phone: 215-746-2081

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 May 2013
Est. completion
1 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Second-phase insulin response during GPA test

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov