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Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Related Diabetes Pancreatic Insufficiency Drug: placebo Drug: repaglinide Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis
Study Start Date : November 2006
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Repaglinide

Arm Intervention/treatment
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.
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.

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.
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




Primary Outcome Measures :
  1. BMI [ Time Frame: 2 year/end of study ]
  2. Body Composition [ Time Frame: 2 year/end of study ]
    Reporting % of Fat and Lean body mass

  3. CRP [ Time Frame: 2 year/end of study ]

Secondary Outcome Measures :
  1. Glucose Tolerance [ Time Frame: 2-year ]
    We completed the OGTT at the 2 year/end of study visit.

  2. Inflammatory Markers [ Time Frame: 2 year/end of study ]
  3. Wt Z Score [ Time Frame: 2 year/end of study ]
  4. Tanner Stage [ Time Frame: 2 year/end of study ]
    Puberty scale measuring 1-5, 1 being least development, 5 being most development.

  5. FEV 1 [ Time Frame: 2 year/end of study ]
    % of lung function

  6. C-Peptide [ Time Frame: 2 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763412


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Arbelaez, Ana Maria
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
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Study Chair: Neil H White, M.D. Washington University School of Medicine
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Responsible Party: Ana Maria Arbelaez, Assistant Professor in Pediatrics, Arbelaez, Ana Maria
ClinicalTrials.gov Identifier: NCT00763412    
Other Study ID Numbers: 05-1109
P60DK020579 ( U.S. NIH Grant/Contract )
First Posted: October 1, 2008    Key Record Dates
Results First Posted: June 5, 2017
Last Update Posted: June 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ana Maria Arbelaez, Arbelaez, Ana Maria:
Cystic Fibrosis
Diabetes
Cystic Fibrosis Related Diabetes
Pre-diabetes
oral hypoglycemic agents
Repaglinide
treatment
inflammatory markers
Lung function
nutrition
Additional relevant MeSH terms:
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Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Fibrosis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hyperglycemia
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs