Cystic Fibrosis (CF) Exacerbation and Insulin Treatment

NCT01149005 | Unknown

• 1 other identifier: CF-Insulin-HMO-CTIL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Impaired Glucose Tolerance; Pulmonary Exacerbation

Keywords

Normal Glucose Tolerance Test; Mixed Meal Tolerance Test; Cystic Fibrosis; Pulmonary Exacerbation; Impaired Glucose Tolerance Test; Insulin Therapy

Outcome Measures

Primary Outcomes (1)

• delta Forced Expiratory Volume in 1 second (FEV1%) predicted

  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).

  day 0 of the pulmonary exacerbation, to day 14 of the pulmonary exacerbation

Secondary Outcomes (1)

• change in Body Mass Index (BMI)

  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).

Study Arms (1)

insulin

EXPERIMENTAL

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

Drug: novorapid / humalog short acting insulin; Drug: Novo Rapid Insulin (Novonordisk)

Interventions

novorapid / humalog short acting insulin DRUG

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

Also known as: Humalog insulin

insulin

Novo Rapid Insulin (Novonordisk) DRUG

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

Also known as: Humalog insulin lispro

insulin

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hospital

Jerusalem, Israel

Location

Related Publications (1)

• 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.

  PMID: 20188638 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Glucose Intolerance

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• David H Zangen, Dr.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 23, 2010

Record last verified: 2010-06

Locations

IL (1)