RECRUITING

Beta-cell Response to Incretin Hormones in Cystic Fibrosis

Conditions

Cystic Fibrosis Pancreatic Insufficiency Diabetes Cystic Fibrosis with Normal Glucose Tolerance Non-Cystic Fibrosis control group

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2013-05

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01851694

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria, 2. Age greater than or equal to 18y on date of consent 3. Pancreatic insufficiency 4. Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia 5. For female subjects, negative urine pregnancy test at enrollment. 1. No history of cystic fibrosis. 2. Age ≥ 18y on date of consent. 3. Recent OGTT consistent with NGT. 4. For female subjects, negative urine pregnancy test at enrollment.	1. Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia (fasting glucose greater than126 mg/dL) 2. History of clinically symptomatic pancreatitis within last year 3. Prior lung or liver transplant 4. Severe CF liver disease, as defined by portal hypertension 5. Fundoplication-related dumping syndrome 6. Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency) 7. Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to study procedures 8. Treatment with oral or intravenous corticosteroids within 6 weeks of study 9. Hemoglobin less than10g/dL, within 90 days of Visit 1 or at Screening 10. Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq/L on non-hemolyzed specimen 11. Inability to perform study specific procedures (MMTT, GPA) 12. Subjects, who in study team opinion, may be non-compliant with study procedures. 1. History of clinically symptomatic pancreatitis. 2. History of liver disease. 3. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject. 4. Hemoglobin \<10g/dL, within 90 days of GPA test or at Screening. 5. Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine \> 2x upper limit of normal (ULN) or potassium \> 5.5mEq/L on non-hemolyzed specimen. 6. Inability to perform study specific procedures (MMTT, GPA). 7. subjects, who in study team opinion, may be non-compliant with study procedures. 8. elevation of serum amylase or lipase \> 1.5x ULN within 90 days of GPA test.

Inclusion Criteria

Exclusion Criteria

1. Confirmed diagnosis of cystic fibrosis, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria,
2. Age greater than or equal to 18y on date of consent
3. Pancreatic insufficiency
4. Recent OGTT consistent with Indeterminate-GT, IGT, CFRD w/o fasting hyperglycemia, or an established diagnosis of CFRD without fasting hyperglycemia
5. For female subjects, negative urine pregnancy test at enrollment.
1. No history of cystic fibrosis.
2. Age ≥ 18y on date of consent.
3. Recent OGTT consistent with NGT.
4. For female subjects, negative urine pregnancy test at enrollment.

1. Established diagnosis of non-CF diabetes (i.e. T1D) or CFRD with fasting hyperglycemia (fasting glucose greater than126 mg/dL)
2. History of clinically symptomatic pancreatitis within last year
3. Prior lung or liver transplant
4. Severe CF liver disease, as defined by portal hypertension
5. Fundoplication-related dumping syndrome
6. Medical co-morbidities that are not CF-related or are unstable per investigator opinion (i.e. history of bleeding disorders, immunodeficiency)
7. Acute illness or changes in therapy (including antibiotics) within 6 weeks prior to study procedures
8. Treatment with oral or intravenous corticosteroids within 6 weeks of study
9. Hemoglobin less than10g/dL, within 90 days of Visit 1 or at Screening
10. Abnormal renal function, within 90 days of Visit 1 or at Screening; defined as Creatinine greater than 2x upper limit of normal (ULN) or potassium greater than 5.5mEq/L on non-hemolyzed specimen
11. Inability to perform study specific procedures (MMTT, GPA)
12. Subjects, who in study team opinion, may be non-compliant with study procedures.
1. History of clinically symptomatic pancreatitis.
2. History of liver disease.
3. History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk to the subject.
4. Hemoglobin \<10g/dL, within 90 days of GPA test or at Screening.
5. Abnormal renal function, within 90 days of GPA test or at Screening; defined as creatinine \> 2x upper limit of normal (ULN) or potassium \> 5.5mEq/L on non-hemolyzed specimen.
6. Inability to perform study specific procedures (MMTT, GPA).
7. subjects, who in study team opinion, may be non-compliant with study procedures.
8. elevation of serum amylase or lipase \> 1.5x ULN within 90 days of GPA test.

Contacts and Locations

Study Contact

Paola Alvarado

CONTACT

215-746-2081

paola.alvarado@pennmedicine.upenn.edu

Principal Investigator

Michael R. Rickels, MD, MS

PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Study Locations (Sites)

Children's Hospital of Philadelphia and University of Pennsylvania

Philadelphia, Pennsylvania, 19060

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Michael R. Rickels, MD, MS, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-05

Study Completion Date2025-12

Study Record Updates

Study Start Date2013-05

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Cystic Fibrosis
Diabetes
Pancreatic insufficiency
Cystic Fibrosis with Normal Glucose Tolerance
Non-Cystic Fibrosis control group

Additional Relevant MeSH Terms

Cystic Fibrosis
Pancreatic Insufficiency