Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Fondazione per la ricerca sulla Fibrosi Cistica.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Fondazione per la ricerca sulla Fibrosi Cistica
ClinicalTrials.gov Identifier:
NCT00687466
First received: May 27, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.


Condition Intervention Phase
Cystic Fibrosis
Glucose Intolerance
Drug: Insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay

Resource links provided by NLM:


Further study details as provided by Fondazione per la ricerca sulla Fibrosi Cistica:

Primary Outcome Measures:
  • Nutritional status evaluated as variations of Z score of BMI [ Time Frame: At recruitment time and at +3, +6, +9, +12, +15, +18 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb) [ Time Frame: At time recruitment and +3,+6,+9+12+15+18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: August 2005
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Insulin yes
Drug: Insulin

Insulin Glargine will be administered subcutaneously at the dosage of 0.1 U/Kg/die for three months. In case no hypoglycemic episodes occur during this period, the dosage will be increased to 0.15 U/Kg/die in occasion of the first control (T1) and will be scheduled for other three months. If even during this latter period no cases no hypoglycemic episodes occur, at the second control (T2) the dosage will be increased to the maximum of 0.2/U/Kg/die. It is generally accepted that the final dosage of glargine can be tailored to each patient, but it should be maintained between 0.1 and 0.2 U/Kg/die.

Glargine should be administered once daily in the morning and always at the same hour.

Other Name: Lantus
No Intervention: 2
Insulin no

Detailed Description:

Diabetes mellitus may often complicate the cystic fibrosis course, and it is usually preceded by a condition defined as glucose intolerance, during which a significant decay of patient's general conditions is observed. A slow release insulin (glargine) has become available in the market for diabetic patients: its characteristics allow for a single daily dose, and no need of repeated daily monitoring of glycemia.

In this randomized controlled clinical trial we evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.

Eligible patients who will accept to participate to this study will be randomly allocated in the group who will or will not receive glargine as additional supportive therapy. Patients will in any case continue the CF therapy prescribed by their treating physicians and their usual diet. All the patients will be evaluated every three months to assess their nutritional, pulmonary and glycometabolic status. The follow-up will continue until the 18th month after the study entry.

  Eligibility

Ages Eligible for Study:   10 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ascertained diagnosis of CF
  • Age ≥ 10 years
  • Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: >140 mg% and <200 mg%) at 2-6 months' interval between each other
  • At least one of the following conditions:

    • BMI (body mass index) < 10th centile for age and sex (according to Rolland Cachera 1991)
    • Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991)
    • FEV1 ≤ 80% of predicted
    • FEV1 decrease ≥ 10% in the last year

Exclusion Criteria:

  • Specific contraindications for the use of glargine
  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: NCT00687466

Locations
Italy
Pediatric Department, General Hospital,CF Center
Cerignola (Foggia), Italy
Ospedale Maggiore Policlinico, Adult CF Center
Milano, Italy
Pediatric Department, Federico II University, Pediatric CF Center
Napoli, Italy
Pediatric Department G.De Cristina Hospital CF Center
Palermo, Italy
Bambino Gesù Hospital CF Center
Roma, Italy
Policlinico Umberto I. CF Center
Roma, Italy
Sponsors and Collaborators
Fondazione per la ricerca sulla Fibrosi Cistica
Investigators
Principal Investigator: Laura Minicucci, MD G.Gaslini Institute Pediatric Department CF Center
  More Information

Publications:

Responsible Party: Laura Minicucci. MD, Genova CF Center Head, Pediatric Department,CF Center Genova, G.Gaslini Institute, Genova, Italy
ClinicalTrials.gov Identifier: NCT00687466     History of Changes
Other Study ID Numbers: FFC #21/2006, eudraCT number 2005-002135-27, IGG-FC-G-01
Study First Received: May 27, 2008
Last Updated: August 3, 2009
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Fondazione per la ricerca sulla Fibrosi Cistica:
Cystic Fibrosis
Glucose Intolerance

Additional relevant MeSH terms:
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
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014