RecruitingNot ApplicableNCT01851694

Beta-cell Response to Incretin Hormones in Cystic Fibrosis

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


Sponsor

University of Pennsylvania

Enrollment

45 participants

Start Date

May 1, 2013

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how beta cells (the insulin-producing cells in the pancreas) respond to incretin hormones — gut-derived hormones like GLP-1 and GIP that normally help stimulate insulin release after eating — in people with cystic fibrosis (CF). Impaired incretin response may contribute to cystic fibrosis-related diabetes (CFRD). You may be eligible if: - You are 18 years or older - You have a confirmed diagnosis of cystic fibrosis with pancreatic insufficiency - Your recent oral glucose tolerance test (OGTT) shows indeterminate or impaired glucose levels, or mild CF-related diabetes (without fasting high blood sugar) - Control subjects: no history of CF, with a normal OGTT result You may NOT be eligible if: - You have established non-CF diabetes (such as Type 1 diabetes) or CFRD with fasting hyperglycemia - You have had a lung or liver transplant - You have had pancreatitis in the past year - You have had antibiotics or corticosteroids within 6 weeks of the study - You have significant anemia, abnormal kidney function, or other major medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGLP-1

Each subject in this arm will receive GLP-1 infusion and a placebo infusion during a GPA test.

DRUGGIP

Each subject in this arm will receive GIP infusion and placebo during a GPA test.


Locations(1)

Children's Hospital of Philadelphia and University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT01851694


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