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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

Must not have

History of clinically symptomatic pancreatitis within last year

Prior lung or liver transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 hours

Awards & highlights

No Placebo-Only Group

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.

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.

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 “Yes” 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had painful pancreatitis in the past year.

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I have had a lung or liver transplant.

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I have had pancreatitis with symptoms before.

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I am unable to undergo certain study-required tests.

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My kidney function is not normal, with high creatinine or potassium levels.

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My kidney function is not normal, with high creatinine or potassium levels.

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I experience symptoms like rapid heartbeat and dizziness after eating, related to a previous stomach surgery.

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I have diabetes (not CF related) with high fasting blood sugar levels.

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I have severe liver disease due to cystic fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 hours

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Second-phase insulin response during GPA test

Secondary study objectives

Change in insulin secretion among CF groups

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

GIP

2017

Completed Phase 1

~170

GLP-1

2014

Completed Phase 4

~470