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Trial record 33 of 35 for:    "Hyperglycemia" | "Insulin Aspart"

Cystic Fibrosis (CF) Exacerbation and Insulin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01149005
Recruitment Status : Unknown
Verified June 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2010
Last Update Posted : June 23, 2010
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Impaired Glucose Tolerance Pulmonary Exacerbation Drug: novorapid / humalog short acting insulin Drug: Novo Rapid Insulin (Novonordisk) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2010
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. delta Forced Expiratory Volume in 1 second (FEV1%) predicted [ Time Frame: day 0 of the pulmonary exacerbation, to day 14 of the pulmonary exacerbation ]
    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 :
  1. 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). ]
    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

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01149005

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Hadassah Hospital Not yet recruiting
Jerusalem, Israel
Contact: David H Zangen, Dr.    97225844111 ext 74488   
Contact: Hila Elyashar-Earon, RD   
Principal Investigator: David H Zangen, Dr.         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: David H Zangen, Dr. Hadassah Medical Organization

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Responsible Party: Dr. Zangen David, Hadassah Medical Center Identifier: NCT01149005     History of Changes
Other Study ID Numbers: CF-Insulin-HMO-CTIL
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: June 23, 2010
Last Verified: June 2010
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:
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Insulin Aspart
Cystic Fibrosis
Glucose Intolerance
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin, Globin Zinc
Insulin Lispro
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs