Beta-cell Response to Incretin Hormones in Cystic Fibrosis

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT01851694
Status
Recruiting
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Conditions

  • Cystic Fibrosis
  • Pancreatic Insufficiency

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 31, 2013
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: GLP-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 the subject repeats the GPA test with a placebo (saline or salt containing solution) infusion.
  • Experimental: GIP 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 be compared when the subject repeats the GPA test with a placebo (saline or salt containing solution) infusion.

Primary Outcome Measure

Second-phase insulin response during GPA test [ Time Frame: 5 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of Philadelphia and University of PennsylvaniaPhiladelphiaPennsylvania19060
Paola Alvarado
[email protected]
215-746-2081
Michael Rickels, M.D., M.S (PRINCIPAL_INVESTIGATOR)
Andrea Kelly, M.D, M.S. (PRINCIPAL_INVESTIGATOR)

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By research site
Children's Hospital of Philadelphia and University of Pennsylvania· Philadelphia, PA

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