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Prevention of Cystic Fibrosis Diabetes (Prevent)

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ClinicalTrials.gov Identifier: NCT00967798
Recruitment Status : Terminated (Could not achieve target enrollment)
First Posted : August 28, 2009
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Arlene Stecenko, Emory University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions: Cystic Fibrosis
Prediabetes
Intervention: Drug: Sitagliptin

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited between May 2010 and August 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Sitagliptin Participants randomized to receive Sitagliptin
Placebo Participants randomized to receive a placebo

Participant Flow:   Overall Study
    Sitagliptin   Placebo
STARTED   17   16 
COMPLETED   8   13 
NOT COMPLETED   9   3 
Withdrawal by Subject                5                2 
Lost to Follow-up                4                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants are included in the baseline analysis.

Reporting Groups
  Description
Sitagliptin Participants randomized to receive Sitagliptin
Placebo Participants randomized to receive a placebo
Total Total of all reporting groups

Baseline Measures
   Sitagliptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   16   33 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      7  41.2%      5  31.3%      12  36.4% 
Between 18 and 65 years      10  58.8%      11  68.8%      21  63.6% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  41.2%      6  37.5%      13  39.4% 
Male      10  58.8%      10  62.5%      20  60.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   6.3%      1   3.0% 
Not Hispanic or Latino      17 100.0%      15  93.8%      32  97.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   5.9%      0   0.0%      1   3.0% 
White      16  94.1%      15  93.8%      31  93.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      1   6.3%      1   3.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   17   16   33 


  Outcome Measures

1.  Primary:   Number of Participants With Conversion to Cystic Fibrosis Related Diabetes   [ Time Frame: Month 15 ]

2.  Secondary:   Change in Beta-cell Disposition Index   [ Time Frame: Baseline through Month 15 ]

3.  Secondary:   Change in Redox Couples Glutathione/Glutathione Disulfide and Cysteine/Cystine   [ Time Frame: Baseline through Month 12 ]

4.  Secondary:   Change in Inflammatory Cytokines   [ Time Frame: Baseline through Month 12 ]

5.  Secondary:   Change in Percent Predicted FEV1   [ Time Frame: Baseline, end of treatment (Month 12 or Month 24) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Poor enrollment lead to early termination of the study and a small sample size for analyses. Equipment failure resulted in loss of serum samples for some of the secondary outcomes.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Arlene Stecenko, MD
Organization: Emory University
phone: 404-712-2657
e-mail: astecen@emory.edu



Responsible Party: Arlene Stecenko, Emory University
ClinicalTrials.gov Identifier: NCT00967798     History of Changes
Other Study ID Numbers: IRB00012724
1R01FD003527-01 ( U.S. FDA Grant/Contract )
First Submitted: August 27, 2009
First Posted: August 28, 2009
Results First Submitted: April 10, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018