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Effects of Pitavastatin on Insulin Sensitivity and Liver Fat

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ClinicalTrials.gov Identifier: NCT02290106
Recruitment Status : Completed
First Posted : November 13, 2014
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Takara Stanley, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Obesity
Fatty Liver, Nonalcoholic
Interventions Drug: pitavastatin
Other: PLACEBO
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Period Title: Overall Study
Started 25 25
Completed 24 23
Not Completed 1 2
Arm/Group Title Pitavastatin Placebo Total
Hide Arm/Group Description

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
(All randomized participants participated in baseline assessments.)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
52.8  (6.5) 52.9  (7) 52.8  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
25
 100.0%
25
 100.0%
50
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 25 participants 25 participants 50 participants
24
  96.0%
21
  84.0%
45
  90.0%
Non-white Number Analyzed 25 participants 25 participants 50 participants
1
   4.0%
3
  12.0%
4
   8.0%
Not Reported Number Analyzed 25 participants 25 participants 50 participants
0
   0.0%
1
   4.0%
1
   2.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
Low density lipoprotein cholesterol (LDL-C, mg/dL)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 24 participants 23 participants 47 participants
116  (18) 125  (22) 120  (20)
[1]
Measure Analysis Population Description: Only participants with baseline and final data were used in the calculation of baseline timepoints.
Fasting glucose (mg/dL)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 24 participants 23 participants 47 participants
98  (9) 97  (9) 97  (9)
[1]
Measure Analysis Population Description: Only participants with baseline and final data were used in the calculation of baseline timepoints.
Homeostasis model of insulin resistance (HOMA-IR)   [1] 
Mean (Standard Deviation)
Unit of measure:  HOMA-IR Score
Number Analyzed 24 participants 23 participants 47 participants
2.1  (1.9) 1.6  (1.0) 1.8  (1.5)
[1]
Measure Analysis Population Description: Only participants with baseline and final data were used in the calculation of baseline timepoints.
Liver fat content (hepatic fat fraction, %)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  %
Number Analyzed 23 participants 18 participants 41 participants
17  (11) 14  (11) 16  (11)
[1]
Measure Description: This is the percent liver fat content as measured by magnetic resonance spectroscopy technique
[2]
Measure Analysis Population Description: Only participants with baseline and final data were used in the calculation of baseline timepoints. Five additional participants (1 pitavastatin & 4 placebo) were unable to complete MRI due to inability to fit in the scanner or unanticipated claustrophobia, and 1 scan had unusable data due to technical error.
1.Primary Outcome
Title Insulin-stimulated Glucose Uptake
Hide Description insulin-stimulated glucose uptake measured by euglycemic hyperinsulinemic clamp
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with results for baseline and final. In addition to 3 participants who did not finish the study, 2 participants were unable to undergo clamp.
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description:

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Overall Number of Participants Analyzed 22 23
Mean (Standard Deviation)
Unit of Measure: mg/kg/minute
5.9  (2.1) 5.9  (1.6)
2.Primary Outcome
Title Liver Fat
Hide Description liver fat content as measured by 1H-magnetic resonance spectroscopy
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with baseline and final data were analyzed. In addition to patients who discontinued from the study, some patients were unable to have MRI scan due to inability to fit in the scanner or unanticipated claustrophobia.
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description:

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Overall Number of Participants Analyzed 21 18
Mean (Standard Deviation)
Unit of Measure: % liver fat (hepatic fat fraction)
17  (11) 14  (10)
3.Secondary Outcome
Title Alanine Aminotransferase (ALT)
Hide Description alanine aminotransferase at the 6 month timepoint
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
all patients with available data at baseline and final
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description:

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Overall Number of Participants Analyzed 24 23
Mean (Standard Deviation)
Unit of Measure: U/L
37  (38) 27  (17)
4.Secondary Outcome
Title Aspartate Aminotransferase (AST)
Hide Description aspartate aminotransferase at 6 month timepoint
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
all patients with available data at baseline and final
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description:

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Overall Number of Participants Analyzed 24 23
Mean (Standard Deviation)
Unit of Measure: U/L
31  (23) 26  (12)
5.Secondary Outcome
Title Hepatic Insulin Sensitivity
Hide Description hepatic insulin sensitivity assessed by glucose infusion rate corrected for fluctuations in serum glucose ("M") during low-dose insulin clamp
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
all patients with available data at baseline and final (note, in addition to 3 patients who discontinued, some patients were unable to undergo clamp procedure)
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description:

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: mg/kg/minute
1.5  (1.0) 1.6  (0.7)
6.Secondary Outcome
Title Hemoglobin A1c (HbA1c)
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description:

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Overall Number of Participants Analyzed 24 23
Mean (Standard Deviation)
Unit of Measure: % (hemoglobin A1c)
5.7  (0.5) 5.7  (0.3)
7.Secondary Outcome
Title Quantitative Insulin Sensitivity Check Index (QUICKI)
Hide Description quantitative insulin sensitivity check index (QUICKI) at 6 months. Measure = 1/((log(glucose in mg/dL) + log(insulin in uU/mL))
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description:

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

Overall Number of Participants Analyzed 21 23
Mean (Standard Deviation)
Unit of Measure: QUICKI index
0.16  (0.02) 0.15  (0.02)
Time Frame 6 months (during study period)
Adverse Event Reporting Description Patients were asked at every study visit to recall any adverse events. (Patients were not contacted following study completion.)
 
Arm/Group Title Pitavastatin Placebo
Hide Arm/Group Description

pitavastatin 4mg daily by mouth for 6 months

pitavastatin

Identical placebo 4mg by mouth daily for 6 months

PLACEBO

All-Cause Mortality
Pitavastatin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Pitavastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/25 (8.00%)      1/25 (4.00%)    
Gastrointestinal disorders     
Pancreatic Cancer   1/25 (4.00%)  1 0/25 (0.00%)  0
Acute appendicitis   0/25 (0.00%)  0 1/25 (4.00%)  1
General disorders     
Chest Pain  [1]  1/25 (4.00%)  1 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Acute chest pain with overnight hospitalization; cardiac etiology ruled out with normal cardiac enzymes and other testing
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pitavastatin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/25 (64.00%)      25/25 (100.00%)    
Gastrointestinal disorders     
Diarrhea or Loose Stools   3/25 (12.00%)  7/25 (28.00%) 
Any Gastrointestinal Symptoms   5/25 (20.00%)  8/25 (32.00%) 
General disorders     
Fatigue   2/25 (8.00%)  5/25 (20.00%) 
Musculoskeletal and connective tissue disorders     
Any Musculoskeletal Symptoms   4/25 (16.00%)  6/25 (24.00%) 
Muscle Cramps   4/25 (16.00%)  4/25 (16.00%) 
Nervous system disorders     
Headache   0/25 (0.00%)  2/25 (8.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Takara Stanley, MD
Organization: Massachusetts General Hospital
Phone: 6177249109
EMail: tstanley@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Takara Stanley, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02290106    
Other Study ID Numbers: 2014p-002117
First Submitted: November 8, 2014
First Posted: November 13, 2014
Results First Submitted: March 22, 2019
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019