Cystic Fibrosis (CF) Exacerbation and Insulin Treatment

NCT ID: NCT01149005

Last Updated: 2010-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of the study is to evaluate whether insulin treatment during pulmonary exacerbation (PE) in patients with Cystic Fibrosis (CF)and normoglycemia improves their short term outcome by normalizing the glycemic profile and enhancing recovery. the investigators would like to evaluate whether insulin treatment during exacerbation improves both the general clinical condition of these patients and also has a protecting effect on ß-cells by preventing the deleterious effect of "chronic" hyperglycemia.

Detailed Description

The life expectancy of patients with cystic fibrosis (CF) has increased over the last decades due to improved understanding of the disease and new treatments. CF patients who live longer develop glucose intolerance and cystic fibrosis related diabetes (CFRD), in fact, routine annual screening by Oral Glucose Tolerance Tests (OGTT) shows that the prevalence of CFRD increases with age. CFRD is primarily an insulinopenic condition characterized by an impaired and delayed insulin secretion, as a consequence of fibrosis in the exocrine pancreatic tissue that compromises the ß-cell function.

The occurrence of CFRD is significantly related to increased morbidity and mortality. Based on data from the CF Patients Registry in the USA, the mortality rate of patients with CFRD is six-fold higher than that of patients without CFRD.

Our pilot study proved that during pulmonary exacerbation (PE), CF patients with Normal Glucose Tolerance (NGT) exhibited early latent diabetic glucose intolerance in Oral Glucose Tolerance Test(OGTT) which becomes completely normalized 3-4 weeks after resolution of PE. These patients who are considered to be normoglycemic may experience relatively long periods of hyperglycemia during recurrent events of pulmonary infections. Chronically increased glucose values during PE have an adverse impact on pulmonary function both during PE and in the long-term. Hyperglycemia may increase the duration and extent of recovery from PE. Furthermore it may impair the ability to overcome lung infections by directly stimulating the growth of respiratory pathogens. Finally, hyperglycemia per-se during stressful conditions may worsen the general outcome.

Insulin therapy is considered routine treatment for patients with CFRD. In addition to normalizing glucose levels, insulin has a beneficial effect on general pulmonary function and nutritional status, possibly due to its anabolic effect. No routine or formal guidelines for treating PE hyperglycemia are currently available. Normal Glucose Tolerance (NGT)patients, who are hyperglycemic during PE only, are generally not intensively treated for this condition, except if the treating physician decides on interventional insulin treatment. Some patients may experience relatively long periods of hyperglycemia during recurrent events of pulmonary infections.

Conditions

Cystic Fibrosis; Impaired Glucose Tolerance; Pulmonary Exacerbation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

insulin

patients who will get insulin with main meals during Intravenous (IV) antibiotic therapy due to pulmonary exacerbation

Group Type: EXPERIMENTAL

novorapid / humalog short acting insulin

Intervention Type: DRUG

1-4 units will be injected Subcutaneously (SC), before every main meal.

Novo Rapid Insulin (Novonordisk)

Intervention Type: DRUG

Novo Rapid Insulin (Novonordisk) will be administered before each main meal 1-4 units depends on the patients weight

Interventions

novorapid / humalog short acting insulin

1-4 units will be injected Subcutaneously (SC), before every main meal.

Intervention Type: DRUG

Novo Rapid Insulin (Novonordisk)

Novo Rapid Insulin (Novonordisk) will be administered before each main meal 1-4 units depends on the patients weight

Intervention Type: DRUG

Other Intervention Names

Humalog insulin; Humalog insulin lispro

Eligibility Criteria

Inclusion Criteria

• Confirmed diagnosis of CF according to standard criteria
• Pancreatic insufficiency
• Age > 10 years
• Normal oral glucose tolerance test (OGTT) in the past 12 month.
• Acute pulmonary exacerbation (PE) according to the treating physician requires treatment with intravenous antibiotics

Exclusion Criteria

• CF-related diabetes/impaired glucose tolerance test (IGTT) in a mixed meal tolerance test performed during full remission from pulmonary exacerbation

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Hadassah Medical Center

Principal Investigators

David H Zangen, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Hadassah Hospital

Jerusalem, , Israel

Countries

Israel

Facility Contacts

David H Zangen, Dr.

Role: primary

ZangenD@hadassah.org.il

97225844111 ext. 74488

Hila Elyashar-Earon, RD

Role: backup

hilae@hadassah.org.il

References

Sc NN, Shoseyov D, Kerem E, Zangen DH. Patients with cystic fibrosis and normoglycemia exhibit diabetic glucose tolerance during pulmonary exacerbation. J Cyst Fibros. 2010 May;9(3):199-204. doi: 10.1016/j.jcf.2010.02.001. Epub 2010 Feb 25.

Reference Type: BACKGROUND

PMID: 20188638 (View on PubMed)

Other Identifiers

CF-Insulin-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id