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

August 3, 2009 updated by: Fondazione per la ricerca sulla Fibrosi Cistica

Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Cerignola (Foggia), Italy
        • Pediatric Department, General Hospital,CF Center
      • Milano, Italy
        • Ospedale Maggiore Policlinico, Adult CF Center
      • Napoli, Italy
        • Pediatric Department, Federico II University, Pediatric CF Center
      • Palermo, Italy
        • Pediatric Department G.De Cristina Hospital CF Center
      • Roma, Italy
        • Bambino Gesù Hospital CF Center
      • Roma, Italy
        • Policlinico Umberto I. CF Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Lantus
NO_INTERVENTION: 2
Insulin no

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nutritional status evaluated as variations of Z score of BMI
Time Frame: At recruitment time and at +3, +6, +9, +12, +15, +18 months
At recruitment time and at +3, +6, +9, +12, +15, +18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb)
Time Frame: At time recruitment and +3,+6,+9+12+15+18 months
At time recruitment and +3,+6,+9+12+15+18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione per la ricerca sulla Fibrosi Cistica

Investigators

  • Principal Investigator: Laura Minicucci, MD, G.Gaslini Institute Pediatric Department CF Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ANTICIPATED)

October 1, 2009

Study Completion (ANTICIPATED)

October 1, 2009

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 29, 2008

First Posted (ESTIMATE)

May 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 4, 2009

Last Update Submitted That Met QC Criteria

August 3, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFC #21/2006
  • eudraCT number 2005-002135-27
  • IGG-FC-G-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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