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Hormone Therapy

Incretin Hormones for Cystic Fibrosis

N/A
Recruiting
Led By Michael R. Rickels, MD, MS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria
Pancreatic insufficiency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 hours
Awards & highlights

Study Summary

This trial is looking at the role of incretin hormones in Cystic Fibrosis patients with normal glucose levels to see if it has an effect on CFTR function.

Who is the study for?
This trial is for adults over 18 with cystic fibrosis and pancreatic insufficiency, who may have glucose tolerance issues but not severe diabetes. Women must test negative for pregnancy. Excluded are those with prior transplants, severe liver disease, abnormal kidney function, certain blood disorders or any condition that could interfere with the study.Check my eligibility
What is being tested?
The study investigates how incretin hormones (GLP-1 and GIP) affect insulin production in cystic fibrosis patients to better understand and treat CFRD. It includes CF patients with normal glucose levels and non-CF controls to compare responses.See study design
What are the potential side effects?
While specific side effects aren't listed here, incretin hormones like GLP-1 and GIP can generally cause digestive issues such as nausea or vomiting, potential pancreatitis risk increase, allergic reactions at injection sites if applicable, and changes in appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check β€œYes” for the criteria below
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I have been diagnosed with cystic fibrosis based on a sweat test or genetic testing.
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My pancreas does not work properly.
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My glucose tolerance test shows I have a form of diabetes related to cystic fibrosis without high blood sugar when fasting.
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I am 18 years old or older.
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I am a woman and my pregnancy test before joining the study was negative.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Second-phase insulin response during GPA test
Secondary outcome measures
Change in insulin secretion among CF groups

Trial Design

2Treatment groups
Experimental Treatment
Group I: GLP-1Experimental Treatment1 Intervention
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.
Group II: GIPExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GLP-1
2014
Completed Phase 4
~470
GIP
2017
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
1,994 Previous Clinical Trials
42,879,211 Total Patients Enrolled
8 Trials studying Cystic Fibrosis
724 Patients Enrolled for Cystic Fibrosis
Children's Hospital of PhiladelphiaOTHER
706 Previous Clinical Trials
8,571,395 Total Patients Enrolled
17 Trials studying Cystic Fibrosis
859 Patients Enrolled for Cystic Fibrosis
Michael R. Rickels, MD, MS4.540 ReviewsPrincipal Investigator - University of Pennsylvania
Forest Hills Hospital, New York Hospital Queens, Queens Hospital Center, Flushing Hospital Medical Center
Medical School - University of Pittsburgh
Icahn School of Medicine at Mount Sinai, Residency in Gastroenterology
5Patient Review
I had a great consultation with Dr. Vogelman. Thank you!

Media Library

GIP (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01851694 β€” N/A
Cystic Fibrosis Research Study Groups: GIP, GLP-1
Cystic Fibrosis Clinical Trial 2023: GIP Highlights & Side Effects. Trial Name: NCT01851694 β€” N/A
GIP (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01851694 β€” N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Dec 2025