Clinical trial NCT00687466: Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
Official title: Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cystic Fibrosis
Glucose Intolerance
Keywords: Cystic Fibrosis
Glucose Intolerance
Lead sponsor: Fondazione per la ricerca sulla Fibrosi Cistica
Sponsor class: OTHER
First posted: 2008-05-30
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Nutritional status evaluated as variations of Z score of BMI
timeFrame: At recruitment time and at +3, +6, +9, +12, +15, +18 months
Secondary outcomes:
measure: Glucose tolerance improvement evaluated as improvement of glycometabolic parameter (glycosylated Hb)
timeFrame: At time recruitment and +3,+6,+9+12+15+18 months
Other outcomes:
Locations:
city: Cerignola (Foggia)
country: Italy
facility: Pediatric Department, General Hospital,CF Center
city: Milano
country: Italy
facility: Ospedale Maggiore Policlinico, Adult CF Center
city: Napoli
country: Italy
facility: Pediatric Department, Federico II University, Pediatric CF Center
city: Palermo
country: Italy
facility: Pediatric Department G.De Cristina Hospital CF Center
city: Roma
country: Italy
facility: Bambino Gesù Hospital CF Center
city: Roma
country: Italy
facility: Policlinico Umberto I. CF Center
Study officials:
affiliation: G.Gaslini Institute Pediatric Department CF Center
name: Laura Minicucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Rafii M, Chapman K, Stewart C, Kelly E, Hanna A, Wilson DC, Tullis E, Pencharz PB. Changes in response to insulin and the effects of varying glucose tolerance on whole-body protein metabolism in patients with cystic fibrosis. Am J Clin Nutr. 2005 Feb;81(2):421-6. doi: 10.1093/ajcn.81.2.421.
citation: Rolon MA, Benali K, Munck A, Navarro J, Clement A, Tubiana-Rufi N, Czernichow P, Polak M. Cystic fibrosis-related diabetes mellitus: clinical impact of prediabetes and effects of insulin therapy. Acta Paediatr. 2001 Aug;90(8):860-7.
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citation: Lombardo F, De Luca F, Rosano M, Sferlazzas C, Lucanto C, Arrigo T, Messina MF, Crisafulli G, Wasniewska M, Valenzise M, Cucinotta D. Natural history of glucose tolerance, beta-cell function and peripheral insulin sensitivity in cystic fibrosis patients with fasting euglycemia. Eur J Endocrinol. 2003 Jul;149(1):53-9. doi: 10.1530/eje.0.1490053.
citation: Bizzarri C, Lucidi V, Ciampalini P, Bella S, Russo B, Cappa M. Clinical effects of early treatment with insulin glargine in patients with cystic fibrosis and impaired glucose tolerance. J Endocrinol Invest. 2006 Mar;29(3):RC1-4. doi: 10.1007/BF03345538.
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