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Beta-cell Response to Incretin Hormones in Cystic Fibrosis 45

Recruiting
Clinical Trial NCT01851694 is an interventional study for Cystic Fibrosis, Pancreatic Insufficiency that is recruiting. It started on May 1, 2013 with plans to enroll 45 participants. Led by University of Pennsylvania, it is expected to complete by December 1, 2026. The latest data from ClinicalTrials.gov was last updated on January 14, 2026.
Brief 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 cel...Show More
Detailed Description
Previously, cystic fibrosis related diabetes (CFRD) was considered to be a consequence of damage to the pancreas therefore the cells contained in the pancreas--i.e.--islets that house beta cells, which make and release insulin (similar to T1D). Recent evidence suggests that other factors may also be associated that are similar to those with T2D. For example, patients with T2D, have decreased secretion of incretins, h...Show More
Official Title

Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis

Conditions
Cystic FibrosisPancreatic Insufficiency
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 817585
NCT ID Number
NCT01851694
Start Date (Actual)
2013-05
Last Update Posted
2026-01-14
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
45
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Cystic Fibrosis
Diabetes
Pancreatic insufficiency
Cystic Fibrosis with Normal Glucose Tolerance
Non-Cystic Fibrosis control group
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGLP-1 Incretin Hormone
The incretin, Glucagon-Like-peptide-1 (GLP-1) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins. (during the GPA for 230 mg/dL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg/dL glucose levels but no incretin will be infused during this part of the test. These data will be compared when t...Show More
GLP-1
Each subject in this arm will receive GLP-1 infusion and a placebo infusion during a GPA test.
ExperimentalGIP Incretin Hormone
The incretin, Glucose-dependent Insulinotropic Polypeptide (GIP) will be infused into the veins starting 30 minutes prior to initiating the GPA test. This infusion will continue for a total of 90 mins (during the GPA for 230 mg/dL glucose levels) and then this will be stopped. The GPA test will be performed for the 340 mg/dL glucose levels but no incretin will be infused during this part of the test. These data will ...Show More
GIP
Each subject in this arm will receive GIP infusion and placebo during a GPA test.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Second-phase insulin response during GPA test
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 infusion will be started in order to raise the level of sugar in the blood to 230 mg/dl. Once the level is achieved, arginine will be injected again and blood samples are measured. After a 2 hour break, the glucose infusion will be started to achieve a blood sugar of 340mg/dl and arginine injection will be repeated. Comparison of responses with incretin vs. placebo will be performed using statistical methods, specifically, paired t-test or Wilcoxon matched pair test.
5 hours
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in insulin secretion among CF groups
The change in second phase insulin secretion induced by incretins will be compared among the different subgroups of patients with CF (Ind-GT, IGT, and early CFRD) groups using nonparametric comparison of changes in slope, estimated using Mann-Whitney methods.
5 hours
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  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.

  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.
University of Pennsylvania logoUniversity of Pennsylvania503 active studies to explore
Children's Hospital of Philadelphia logoChildren's Hospital of Philadelphia
Study Responsible Party
Michael R. Rickels, MD, MS, Principal Investigator, Professor of Medicine, University of Pennsylvania
Study Central Contact
Contact: Paola Alvarado, 215-746-2081, [email protected]
1 Study Locations in 1 Countries

Pennsylvania

Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, Pennsylvania, 19060, United States
Paola Alvarado, Contact, 215-746-2081, [email protected]
Michael Rickels, M.D., M.S, Principal Investigator
Andrea Kelly, M.D, M.S., Principal Investigator
Recruiting