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NCT01851694 · ClinicalTrials.gov registry record · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
A NA study of Cystic Fibrosis and Pancreatic Insufficiency, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT01851694: Recruiting NA study of Cystic Fibrosis and Pancreatic Insufficiency, sponsored by University of Pennsylvania.
NCT01851694 is a NA study of Cystic Fibrosis and Pancreatic Insufficiency that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 45 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851694, a NA study of Cystic Fibrosis and Pancreatic Insufficiency, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Insulin is a hormone which is made by cells in the pancreas and helps carry glucose (sugar) from the food we eat to the cells of the body for energy. While cystic fibrosis related diabetes (CFRD) has many features similar to both T1D and T2D, patients with CF may not have the same symptoms as either T1D or T2D patients. Currently, there is little understanding of CFRD and the best options for treatment remain unclear. The purpose of this research study is to examine and understand the various mechanisms that contribute to CFRD and gain a better understanding of potential means to treat CFRD. In particular, we plan to study the effects of incretin hormones that can enhance insulin production in CF patients. Enrollment is complete for the protocol as initially written. In order to further study the role of the incretin hormone on Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) function , we have received approval to extend our investigation to include the following study groups: * Cystic Fibrosis participants with normal glucose tolerance * Non-Cystic Fibrosis controls
Primary Outcome
The key endpoint of interest will be the change in second phase insulin response derived from the Glucose-Potentiated Arginine (GPA) test. The GPA test will measure insulin (and other glucose controlling hormones) which will be a measure of pancreatic endocrine function in response to injection of arginine. Arginine is a naturally occurring amino acid (substance) in the body. It will be given in the veins to make the pancreas secrete insulin. After the first injection of arginine, a glucose infu
Conditions Studied
Interventions
- DRUG GLP-1
- DRUG GIP
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia and University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-05 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT01851694 shows while recruiting
NCT01851694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (75% lower).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which GLP-1 is the first listed.
NCT01851694 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01851694 about?
NCT01851694 is a clinical study titled "Beta-cell Response to Incretin Hormones in Cystic Fibrosis". In recent years, diabetes has emerged as one of the most significant co-diseases that many Cystic Fibrosis (CF) patients develop. Type 1 (T1D) and Type 2 (T2D) diabetes results when either the body does not make enough insulin or the body does not respond correctly to this insulin, respectively. Ins...
What is the current status of trial NCT01851694?
This trial is currently recruiting. It is a NA study. The enrollment target is 45 participants. The study started on 2013-05. Estimated completion is 2026-12.
What conditions does trial NCT01851694 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Pancreatic Insufficiency.
What interventions are being tested in trial NCT01851694?
The interventions under investigation include: GLP-1 (DRUG), GIP (DRUG).
Who is sponsoring clinical trial NCT01851694?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01851694 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01851694's enrollment target sits among peer trials
45 94th of 169 higher than 76 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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