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Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

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: NCT00782795
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : December 11, 2017
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Chronic Pancreatitis
Insulin Resistance
Normal or Mildly Abnormal Stool Fat Levels
Interventions: Drug: Pioglitazone
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
39 screen fails did not go on to randomization

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
Pioglitazone

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Sugar Pill (Placebo)

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.


Participant Flow:   Overall Study
    Pioglitazone   Sugar Pill (Placebo)
STARTED   17   8 
6 Weeks (1st Apptment)   16   7 
24 Week Appointment   16   7 
COMPLETED   16   6 
NOT COMPLETED   1   2 
Withdrawal by Subject                1                2 



  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.
No text entered.

Reporting Groups
  Description
Pioglitazone

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Sugar Pill (Placebo)

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Total Total of all reporting groups

Baseline Measures
   Pioglitazone   Sugar Pill (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   8   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.35  (7.61)   48.37  (9.83)   51.08  (8.39) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  29.4%      2  25.0%      7  28.0% 
Male      12  70.6%      6  75.0%      18  72.0% 
Region of Enrollment 
[Units: Participants]
     
United States   17   8   25 


  Outcome Measures

1.  Primary:   Glucose Tolerance at 24 Weeks   [ Time Frame: 24 weeks ]

2.  Primary:   Glucose Tolerance at 48 Weeks   [ Time Frame: 48 weeks ]

3.  Primary:   Insulin Sensitivity Index for Glycemia at 24 Weeks   [ Time Frame: 24 weeks ]

4.  Primary:   Insulin Sensitivity Index for Glycemia at 48 Weeks.   [ Time Frame: 48 weeks ]

5.  Secondary:   Beta-cell Function   [ Time Frame: 24, 48 weeks ]

6.  Secondary:   Insulin Resistance at 24 and 48 Weeks   [ Time Frame: 24, 48 weeks ]

7.  Secondary:   Pancreas Ultrasound Appearance   [ Time Frame: 48 weeks ]

8.  Secondary:   Quality of Life   [ Time Frame: 24, 48 weeks ]

9.  Secondary:   Number and Percentage of Participants With Steatorrhea   [ Time Frame: 48 weeks ]

10.  Secondary:   Pain   [ Time Frame: 12, 24, 36, 48 and 60 weeks ]

11.  Secondary:   Body Mass Index (BMI)   [ Time Frame: 12, 24, 36, 48 and 60 weeks ]

12.  Secondary:   Hospitalizations   [ Time Frame: 12, 24, 36, 48 and 60 weeks ]

13.  Secondary:   Missed Work   [ Time Frame: 12, 24, 36, 48, 60 weeks ]

14.  Secondary:   Insulin Sensitivity (%S)   [ Time Frame: 24 and 48 weeks ]


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Matthew DiMagno
Organization: University of Michigan
e-mail: mdimagno@umich.edu



Responsible Party: Matthew DiMagno, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00782795     History of Changes
Other Study ID Numbers: CP-PENQEX-1R21AA017271
R21AA017271 ( U.S. NIH Grant/Contract )
1R21AA017271-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: September 19, 2017
Results First Posted: December 11, 2017
Last Update Posted: January 11, 2018