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Effect of Salicylate on Glucose Metabolism in Insulin Resistance States

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: NCT00258128
Recruitment Status : Completed
First Posted : November 24, 2005
Results First Posted : April 30, 2019
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Condition Insulin Resistance
Interventions Drug: Salsalate
Drug: Placebo
Enrollment 17
Recruitment Details This study was active between 2000-2008. The location was an accademic clinic setting in the USA.
Pre-assignment Details Subjects were instructed to monitor fasting blood glucose levels and with symptoms of hyperglycemia or hypoglycemia, and to avoid changing dietary or exercise habits.
Arm/Group Title Salsalate 4.0 g/d Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 8 9
Completed 8 9
Not Completed 0 0
Arm/Group Title Salsalate Placebo Total
Hide Arm/Group Description Randomized cohorts - Active Randomized cohorts - Placebo Total of all reporting groups
Overall Number of Baseline Participants 8 9 17
Hide Baseline Analysis Population Description
This trial planned 8-9 participants per arm.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
 100.0%
9
 100.0%
17
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 9 participants 17 participants
51  (12) 54  (8) 52  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 9 participants 17 participants
Female
5
  62.5%
4
  44.4%
9
  52.9%
Male
3
  37.5%
5
  55.6%
8
  47.1%
1.Primary Outcome
Title Glucose
Hide Description fasting glucose
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Receiving one dose of study drug and with measured value
Arm/Group Title Placebo Salsalate
Hide Arm/Group Description:
Fasting glucose
Fasting glucose
Overall Number of Participants Analyzed 9 8
Mean (Standard Deviation)
Unit of Measure: mmol/L
7.1  (0.3) 6.4  (0.3)
2.Secondary Outcome
Title Adiponectin
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salsalate Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 8 9
Mean (Standard Deviation)
Unit of Measure: mg/ml
22.7  (2.5) 10.6  (2.0)
Time Frame one month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Salsalate Placebo
Hide Arm/Group Description Active Drug Placebo - for salsalate
All-Cause Mortality
Salsalate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Hide Serious Adverse Events
Salsalate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Salsalate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/9 (0.00%) 

Small study size, sort duration of treatment, multiple endpoints.

See manuscript:

Goldfine AB, et al. Clin Transl Sci. 2008 May;1(1):36-43.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Allison B. Goldfine, MD
Organization: Joslin Diabetes Center
Phone: 617-309-2400
EMail: allison.goldfine@joslin.harvard.edu
Layout table for additonal information
Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00258128    
Other Study ID Numbers: CHS 00-01
R37DK051729 ( U.S. NIH Grant/Contract )
R01DK051729 ( U.S. NIH Grant/Contract )
First Submitted: November 22, 2005
First Posted: November 24, 2005
Results First Submitted: December 17, 2012
Results First Posted: April 30, 2019
Last Update Posted: April 30, 2019