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Trial record 1 of 4 for:    repaglinide | Cystic Fibrosis
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Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT00763412
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : June 5, 2017
Last Update Posted : June 5, 2017
Sponsor:
Collaborators:
Washington University School of Medicine
National Institutes of Health (NIH)
Novo Nordisk A/S
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ana Maria Arbelaez, Arbelaez, Ana Maria

Tracking Information
First Submitted Date  ICMJE September 29, 2008
First Posted Date  ICMJE October 1, 2008
Results First Submitted Date  ICMJE July 11, 2016
Results First Posted Date  ICMJE June 5, 2017
Last Update Posted Date June 5, 2017
Study Start Date  ICMJE November 2006
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • BMI [ Time Frame: 2 year/end of study ]
  • Body Composition [ Time Frame: 2 year/end of study ]
    Reporting % of Fat and Lean body mass
  • CRP [ Time Frame: 2 year/end of study ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
feasibility [ Time Frame: every 3 months for 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • Glucose Tolerance [ Time Frame: 2-year ]
    We completed the OGTT at the 2 year/end of study visit.
  • Inflammatory Markers [ Time Frame: 2 year/end of study ]
  • Wt Z Score [ Time Frame: 2 year/end of study ]
  • Tanner Stage [ Time Frame: 2 year/end of study ]
    Puberty scale measuring 1-5, 1 being least development, 5 being most development.
  • FEV 1 [ Time Frame: 2 year/end of study ]
    % of lung function
  • C-Peptide [ Time Frame: 2 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
1.BMI, z-score, DEXA scan,2.FEV1, FVC, 3.HOMA, QUICKI, 4.systemic inflammatory markers. [ Time Frame: Every 3-6 months over a 2-year period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
Official Title  ICMJE Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
Brief Summary The purpose of this study is to provide the necessary data and experience to design a larger, full scale clinical trial to determine if a certain medicine (repaglinide), which increases the amount of insulin secreted by the pancreas, can improve the nutritional status and pulmonary function of adolescents and young adults with cystic fibrosis and prediabetes by improving blood glucose control. The investigators are also trying to determine the relationship between systemic inflammatory factors and glucose impairment.
Detailed Description

As people with Cystic Fibrosis (CF) are living well into adulthood new complications are arising. CF-Related Diabetes (CFRD) has emerged as a major complication. Years prior to the diagnosis of CFRD, patients have decreasing insulin secretion, glucose intolerance, deteriorating pulmonary function, and nutritional impairment. There are no current standard recommendations for the treatment of CF patients with prediabetes, and there is little evidence that treatment of this prediabetic state in CF patients will prevent the deterioration of the lung function, nutritional status and potentially slow the progression to manifest CFRD.

To determine the feasibility of testing this hypothesis, we will perform a pilot, double-blinded, randomized controlled trial in 20 CF pancreatic insufficient patients ages of 12 to 24 years old with impaired glucose tolerance test (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) and assign them to either placebo or Repaglinide 0.5 mg PO 3 - 4 times a day before meals for two years. Patients will monitor their blood glucose daily and will be followed every 3 months for 2 years to determine changes in nutritional status by BMI and DEXA, lung function tests, frequency of hospitalizations, antibiotic courses, and degree of glucose tolerance, insulin secretion and insulin sensitivity.

In addition, based on the evidence of increased inflammation in type 2 diabetes, correlation of systemic inflammatory response at different degrees of glucose tolerance and after treatment, will be assessed in these subjects, as well as in another 20 CF pancreatic insufficient matched patients with normal glucose tolerance who will be studied once without intervention

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Cystic Fibrosis Related Diabetes
  • Pancreatic Insufficiency
Intervention  ICMJE
  • Drug: placebo
    CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with placebo by taking 1 pill before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
  • Drug: repaglinide
    CF pancreatic insufficient patients with impaired glucose tolerance (IGT) or CFRD without fasting hyperglycemia (CFRD-No FH) by OGTT will be treated with repaglinide 0.5 mg before each meal that contains more than 20 grams of carbohydrate 3-4 times a day for 2 years.
    Other Name: Prandin
Study Arms  ICMJE
  • Placebo Comparator: 1 Placebo
    1 pill before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance. Subjects were randomized to placebo or drug.
    Intervention: Drug: placebo
  • Experimental: 2. repaglinide
    repaglinide 0.5 mg before each meal 3-4 times a day for 2 years. All subjects had abnormal glucose tolerance.Subjects were randomized to placebo or drug.
    Intervention: Drug: repaglinide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2017)
31
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
40
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or females 12 -24 years old
  • Diagnosis of Cystic Fibrosis by sweat test with exocrine pancreatic insufficiency
  • Must have a glucose pattern by Oral Glucose Tolerance Test with fasting blood glucose <126 mg/dl and 2 hour: 140 - 199 mg/dl or >200 mg/dl.
  • Weight must be stable within 5% for 3 months prior to initiation visit
  • Must be able to reproducibly perform spirometry based on American Thoracic Society guidelines

Exclusion Criteria:

  • Patients receiving growth hormone therapy or taking insulin
  • Patients with evidence of liver dysfunction
  • Patients who are status-post lung or liver transplantation
  • Patients who have received systemic steroids for more than 28 days during the 6 months prior to the study
  • Patients with active ABPA on steroids
  • Patients taking medications that affect glucose metabolism or contraindicated with repaglinide
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00763412
Other Study ID Numbers  ICMJE 05-1109
P60DK020579 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: The outcome was inconclusive for this hypothesis, but the data may be valuable in future research. We are not currently sharing data from this project.
Responsible Party Ana Maria Arbelaez, Arbelaez, Ana Maria
Study Sponsor  ICMJE Arbelaez, Ana Maria
Collaborators  ICMJE
  • Washington University School of Medicine
  • National Institutes of Health (NIH)
  • Novo Nordisk A/S
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Study Chair: Neil H White, M.D. Washington University School of Medicine
PRS Account Arbelaez, Ana Maria
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP