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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00763412
Other study ID # 05-1109
Secondary ID
Status Completed
Phase N/A
First received September 29, 2008
Last updated January 28, 2013
Start date November 2006
Est. completion date January 2013

Study information

Verified date January 2013
Source Arbelaez, Ana Maria
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 24 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Intervention

Drug:
placebo
CF pancreatic insufficient patients with prediabetes 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.
repaglinide
CF pancreatic insufficient patients with prediabetes 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.

Locations

Country Name City State
United States Washington University School of Medicine St. Louis Missouri

Sponsors (4)

Lead Sponsor Collaborator
Arbelaez, Ana Maria National Institutes of Health (NIH), Novo Nordisk A/S, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary feasibility every 3 months for 2 years No
Secondary 1.BMI, z-score, DEXA scan,2.FEV1, FVC, 3.HOMA, QUICKI, 4.systemic inflammatory markers. Every 3-6 months over a 2-year period No
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