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Trial record 44 of 52 for:    phenylbutyrate

Effect of Endoplasmic Reticulum Stress on Metabolic Function (TUDCA/PBA)

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ClinicalTrials.gov Identifier: NCT00771901
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Basic Science
Conditions: Insulin Resistance
Diabetes
Obesity
Interventions: Drug: tauroursodeoxycholic acid
Other: placebo
Drug: sodium phenylbutyrate

  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 will be recruited by reviewing the VFH database pf research subjects and by local postings. Potential subjects will be contacted by telephone for an initial pre-screen, at which time the study is discussed and a brief medical history and concomitant medication list is obtained. ICF will be sent to interested subjects.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening tests to determine eligibility included: medical hx & PE, blood tests, resting ECG, OGTT, MRI/MRS/MRE of abdomen/liver, and DEXA scan. Two baseline metabolism studies prior to study drug intervention. There were 67 screen fails, 4 subjects withdrew consent before beginning study intervention.

Reporting Groups
  Description
Placebo

Subjects will be given a placebo rather than tauroursodeoxycholic acid.

placebo: 7 pills daily for 4 weeks

Tauroursodeoxycholic Acid

Subjects will receive tauroursodeoxycholic acid for four weeks.

tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner.

Sodium Phenylbutyrate

Subjects will receive sodium phenylbutyrate for four weeks.

sodium phenylbutyrate: 20g/day for four weeks.


Participant Flow:   Overall Study
    Placebo   Tauroursodeoxycholic Acid   Sodium Phenylbutyrate
STARTED   10   10   10 
COMPLETED   10   10   6 
NOT COMPLETED   0   0   4 
Dissat w/# of study medication (40/day)                0                0                4 



  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
Placebo

Subjects will be given a placebo rather than tauroursodeoxycholic acid.

placebo: 7 pills daily for 4 weeks

Tauroursodeoxycholic Acid

Subjects will receive tauroursodeoxycholic acid for four weeks.

tauroursodeoxycholic acid: 1750 mg/day for four weeks. Seven pills daily, 2 with breakfast, 2 with lunch, and 3 with dinner.

Sodium Phenylbutyrate

Subjects will receive sodium phenylbutyrate for four weeks.

sodium phenylbutyrate: 20g/day for four weeks.

Total Total of all reporting groups

Baseline Measures
   Placebo   Tauroursodeoxycholic Acid   Sodium Phenylbutyrate   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   6   26 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      10 100.0%      6 100.0%      26 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (14)   47  (9)   49  (8)   47  (10.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      6  60.0%      6  60.0%      2  33.3%      14  53.8% 
Male      4  40.0%      4  40.0%      4  66.7%      12  46.2% 
Region of Enrollment 
[Units: Participants]
       
United States   10   10   6   26 


  Outcome Measures

1.  Primary:   Body Composition   [ Time Frame: Baseline and four weeks ]

2.  Secondary:   Insulin Sensitivity in the Liver   [ Time Frame: Baseline and four weeks ]

3.  Secondary:   VLDL-triglyceride (TG) Concentration   [ Time Frame: Baseline and four 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: Samuel Klein, M.D.
Organization: Washington University School of Medicine in Saint Louis, Missouri
phone: 314-362-8708
e-mail: sklein@wustl.edu


Publications of Results:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00771901     History of Changes
Other Study ID Numbers: 07-1114
First Submitted: October 10, 2008
First Posted: October 15, 2008
Results First Submitted: September 15, 2017
Results First Posted: May 28, 2018
Last Update Posted: May 28, 2018