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

Sponsored by:	Fondazione per la ricerca sulla Fibrosi Cistica
Information provided by:	Fondazione per la ricerca sulla Fibrosi Cistica
ClinicalTrials.gov Identifier:	NCT00687466

Purpose

The purpose of this study is 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 III

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Insulin Insulin glargine Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay

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:	December 2009
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention Insulin no

Arms

Assigned Interventions

1: Experimental

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.

2: No Intervention

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687466

Contacts

Contact: Riccardo Haupt, MD	39-010-563-6301	riccardohaupt@ospedale-gaslini.ge.it
Contact: Rosaria Casciaro, MD	39-010-563-6564	rosariacasciaro@ospedale-gaslini.ge.it

Locations

Italy
Bambino Gesù Hospital CF Center	Recruiting
Roma, Italy
Contact: Vincenzina Lucidi, MD lucidi@opbg.net
Policlinico Umberto I. CF Center	Recruiting
Roma, Italy
Contact: Serena Bertasi, MD s.bertasi@policlinicoumberto1.it
Pediatric Department G.De Cristina Hospital CF Center	Recruiting
Palermo, Italy
Contact: Gabriella Traverso g.traverso@libero.it
Ospedale Maggiore Policlinico, Adult CF Center	Recruiting
Milano, Italy
Contact: Alice Monti mariaalice.monti@unimi.it
Pediatric Department, General Hospital,CF Center	Recruiting
Cerignola (Foggia), Italy
Contact: Luigi Ratclif ratclif@freemail.it
Pediatric Department, Federico II University, Pediatric CF Center	Recruiting
Napoli, Italy
Contact: Valeria Raia raia@unina.it

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:

Moran A, Hardin D, Rodman D, Allen HF, Beall RJ, Borowitz D, Brunzell C, Campbell PW 3rd, Chesrown SE, Duchow C, Fink RJ, Fitzsimmons SC, Hamilton N, Hirsch I, Howenstine MS, Klein DJ, Madhun Z, Pencharz PB, Quittner AL, Robbins MK, Schindler T, Schissel K, Schwarzenberg SJ, Stallings VA, Zipf WB, et al. Diagnosis, screening and management of cystic fibrosis related diabetes mellitus: a consensus conference report. Diabetes Res Clin Pract. 1999 Aug;45(1):61-73. Review. No abstract available.

Mackie AD, Thornton SJ, Edenborough FP. Cystic fibrosis-related diabetes. Diabet Med. 2003 Jun;20(6):425-36. Review.

Solomon MP, Wilson DC, Corey M, Kalnins D, Zielenski J, Tsui LC, Pencharz P, Durie P, Sweezey NB. Glucose intolerance in children with cystic fibrosis. J Pediatr. 2003 Feb;142(2):128-32.

Lanng S, Thorsteinsson B, Nerup J, Koch C. Influence of the development of diabetes mellitus on clinical status in patients with cystic fibrosis. Eur J Pediatr. 1992 Sep;151(9):684-7.

Milla CE, Warwick WJ, Moran A. Trends in pulmonary function in patients with cystic fibrosis correlate with the degree of glucose intolerance at baseline. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):891-5.

Dobson L, Hattersley AT, Tiley S, Elworthy S, Oades PJ, Sheldon CD. Clinical improvement in cystic fibrosis with early insulin treatment. Arch Dis Child. 2002 Nov;87(5):430-1. No abstract available.

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.

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.

Nousia-Arvanitakis S, Galli-Tsinopoulou A, Karamouzis M. Insulin improves clinical status of patients with cystic-fibrosis-related diabetes mellitus. Acta Paediatr. 2001 May;90(5):515-9.

Dobson L, Sheldon CD, Hattersley AT. Conventional measures underestimate glycaemia in cystic fibrosis patients. Diabet Med. 2004 Jul;21(7):691-6.

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.

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.

Bismuth E, Laborde K, Taupin P, Velho G, Ribault V, Jennane F, Grasset E, Sermet I, de Blic J, Lenoir G, Robert JJ. Glucose tolerance and insulin secretion, morbidity, and death in patients with cystic fibrosis. J Pediatr. 2008 Apr;152(4):540-5, 545.e1. Epub 2007 Nov 26.

Responsible Party:	Pediatric Department,CF Center Genova, G.Gaslini Institute, Genova, Italy ( Laura Minicucci. MD, Genova CF Center Head )
Study ID Numbers:	FFC #21/2006, eudraCT number 2005-002135-27, IGG-FC-G-01
Study First Received:	May 27, 2008
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00687466
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Fondazione per la ricerca sulla Fibrosi Cistica:

Cystic Fibrosis
Glucose Intolerance

Study placed in the following topic categories:

Metabolic Diseases
Fibrosis
Glucose Intolerance
Insulin
Digestive System Diseases
Hyperglycemia
Cystic Fibrosis
Respiratory Tract Diseases

Genetic Diseases, Inborn
Lung Diseases
Glargine
Pancreatic Diseases
Infant, Newborn, Diseases
Metabolic disorder
Glucose Metabolism Disorders
Cystic fibrosis

Additional relevant MeSH terms:

Hypoglycemic Agents
Pathologic Processes
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009