Cystic Fibrosis (CF) Exacerbation and Insulin Treatment

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2010 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01149005
First received: June 9, 2010
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Impaired Glucose Tolerance
Pulmonary Exacerbation
Drug: novorapid / humalog short acting insulin
Drug: Novo Rapid Insulin (Novonordisk)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • delta Forced Expiratory Volume in 1 second (FEV1%) predicted [ Time Frame: day 0 of the pulmonary exacerbation, to day 14 of the pulmonary exacerbation ] [ Designated as safety issue: No ]
    change in lung function parameter %FEV1 predected from baseline before the exacerbatio to day 0, the day of hospitalization due to the pulmonary exacerbation and to day 14, after 2 weeks of Intra Venous (IV)Antibiotic therapy, due to Pulmonary Exacerbation (PE).


Secondary Outcome Measures:
  • change in Body Mass Index (BMI) [ Time Frame: baseline BMI will be compared with BMI on day 0- the day of hospitalization due to the pulmonary exacerbation, and to day 14, after 2 weeks of Intra Venous (IV)Antibiotic therapy, due to Pulmonary Exacerbation (PE). ] [ Designated as safety issue: No ]
    weight and hight will be measured on arrival to hospital (day 0)of the pulmonary exacerbation and again on day 14 of the pulmonary exacerbation and. BMI will be calculated and compared to BMI perior to the exacerbation


Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin
patients who will get insulin with main meals during Intravenous (IV) antibiotic therapy due to pulmonary exacerbation
Drug: novorapid / humalog short acting insulin
1-4 units will be injected Subcutaneously (SC), before every main meal.
Other Name: Humalog insulin
Drug: Novo Rapid Insulin (Novonordisk)
Novo Rapid Insulin (Novonordisk) will be administered before each main meal 1-4 units depends on the patients weight
Other Name: Humalog insulin lispro

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01149005

Locations
Israel
Hadassah Hospital Not yet recruiting
Jerusalem, Israel
Contact: David H Zangen, Dr.    97225844111 ext 74488    ZangenD@hadassah.org.il   
Contact: Hila Elyashar-Earon, RD       hilae@hadassah.org.il   
Principal Investigator: David H Zangen, Dr.         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: David H Zangen, Dr. Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Dr. Zangen David, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT01149005     History of Changes
Other Study ID Numbers: CF-Insulin-HMO-CTIL
Study First Received: June 9, 2010
Last Updated: June 22, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Normal Glucose Tolerance Test
Mixed Meal Tolerance Test
Cystic Fibrosis
Pulmonary Exacerbation
Impaired Glucose Tolerance Test
Insulin Therapy

Additional relevant MeSH terms:
Insulin
Insulin Lispro
Insulin, Globin Zinc
Insulin, Short-Acting
Cystic Fibrosis
Fibrosis
Glucose Intolerance
Digestive System Diseases
Genetic Diseases, Inborn
Glucose Metabolism Disorders
Hyperglycemia
Infant, Newborn, Diseases
Lung Diseases
Metabolic Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 22, 2014