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OpenTrials
Completed

NCT Number: NCT00476281

Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.

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Key information

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Robert Debré - CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients 10 years and older with cystic fibrosis
  • not known diabetics with fasting blood glucose <1.26 g / l
  • outside periods of exacerbation and / or glucocorticoid therapy
  • affiliated to a social security scheme
  • having received the results of the mandatory medical examination
  • having signed an informed consent

Exclusion criteria

  • Patient transplanted lung and / or liver
  • Subject during participation in an interventional clinical trial
  • unable to give informed about the information
  • patient under judicial protection
  • patient under tutorship or curatorship
  • pregnancy
  • breastfeeding
  • patient treated with the combination lumacaftor and ivacaftor

Treatment and study plan

Urinary collect

Procedure

Continuous Glucose Monitoring System (CGMS)

Procedure

Primary outcomes

  1. nutritional and respiratory parameters

    Time frame: five years

    descriptive comparison of nutritional and respiratory parameters in function abnormalities glucose tolerance.

Secondary outcomes

  1. abnormal glucose tolerance

    Time frame: five tears

    assess the prevalence of abnormal glucose tolerance.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Collaborators

  • Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine

Registry information

Official study title

Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis

Important dates

Study start
2008
Primary completion
2020
Study completion
2020
First posted
May 21, 2007
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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