Beta-cell Response to Incretin Hormones in Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT01851694|
Recruitment Status : Recruiting
First Posted : May 10, 2013
Last Update Posted : September 4, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Pancreatic Insufficiency||Drug: GLP-1 Drug: GIP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||June 2021|
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 the subject repeats the GPA test with a placebo (saline or salt containing solution) infusion.
Each subject in this arm will receive GLP-1 infusion and a placebo infusion during a GPA test.
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 be compared when the subject repeats the GPA test with a placebo (saline or salt containing solution) infusion.
Each subject in this arm will receive GIP infusion and placebo during a GPA test.
Other Name: Glucose-dependent insulinotrophic polypeptide
- Second-phase insulin response during GPA test [ Time Frame: 5 hours ]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.
- Change in insulin secretion among CF groups [ Time Frame: 5 hours ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851694
|Contact: Christina Kubrakfirstname.lastname@example.org|
|Contact: Kathryn Gallagher||215-746-2081||Kathryn.Gallagher2@pennmedicine.upenn.edu|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia and University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19060|
|Contact: Christina Kubrak 267-426-5135 email@example.com|
|Principal Investigator: Michael Rickels, M.D., M.S|
|Principal Investigator: Andrea Kelly, M.D, M.S.|
|Principal Investigator:||Michael R. Rickels, MD, MS||University of Pennsylvania|