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The Effects of Anti-Inflammatory Treatment on Insulin Resistance in Healthy Volunteers

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: June 21, 2006
Last Update Posted: March 6, 2013
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.
Information provided by (Responsible Party):
Clifton Bogardus, National Institutes of Health Clinical Center (CC)
Results First Submitted: December 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
Interventions: Drug: Salsalate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment location: clinical research unit at the NIDKK (Phoenix, AZ, USA)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Upon admission, all participants were placed on a weight maintaining diet (containing 50% of energy as carbohydrate, 30% as fat and 20% as protein). Body composition was measured by dual-energy x-ray absorptiometry. At least 3 days after admission and after a 12 h overnight fast a 2-h 75 g OGTT was performed to exclude diabetes.

Reporting Groups
Salsalate The intervention was salsalate (3g/day) for 7 days
Placebo Placebo for 7 days.

Participant Flow:   Overall Study
    Salsalate   Placebo
STARTED   28   26 
COMPLETED   22   18 
Withdrawal by Subject                1                2 
toothache                0                1 
indigestion                0                1 
Chest pain                0                1 
minor infection                0                1 
Poor venous access                2                2 
anaemia or excess drop in glycaemia                2                0 
Error in data records                1                0 

  Baseline Characteristics
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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
Salsalate Salsalate (3g/day) for 7 days
Placebo Identical placebo for 7 days
Total Total of all reporting groups

Baseline Measures
   Salsalate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 22   18   40 
[Units: Years]
Mean (Standard Deviation)
 29  (7)   33  (8)   31  (7.5) 
[Units: Participants]
Female   12   9   21 
Male   10   9   19 
Race/Ethnicity, Customized 
[Units: Participants]
Hispanic   0   1   1 
White   3   3   6 
Native American   19   14   33 
Region of Enrollment 
[Units: Participants]
United States   22   18   40 
[Units: Kg/m2]
Mean (Standard Deviation)
 37  (5)   38  (6)   37.5  (5.5) 
Body Fat 
[Units: % body fat]
Mean (Standard Deviation)
 38  (6)   38  (7)   38  (6.5) 
Fasting plasma glucose 
[Units: Mmol/l]
Median (Standard Deviation)
 5.11  (0.33)   5.06  (0.33)   5.09  (0.33) 
2 hour plasma glucose 
[Units: Mmol/l]
Mean (Standard Deviation)
 6.67  (1.17)   6.61  (1.83)   6.64  (1.50) 
Fasting plasma insulin 
[Units: Pmol/l]
Median (Full Range)
 (56 to 104) 
 (49 to 90) 
 (49 to 104) 
Basal EGP 
[Units: Micro-mol/(kg*min)]
Mean (Standard Deviation)
 10  (2)   11  (2)   10.5  (2) 
Clamp R_d 
[Units: Micro-mol/(kg*min)]
Median (Full Range)
 (11 to 15) 
 (13 to 20) 
 (11 to 20) 

  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Fasting Plasma Glucose Concentration   [ Time Frame: 7 days ]

2.  Primary:   Change in the Average Serum Insulin Concentration During the Last 40 Min of Clamp   [ Time Frame: last 40 min of clamp ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Jonathan Krakoff, M.D./National Institute of Diabetes and Digestive and Kidney Diseases
Organization: National Institutes of Health
phone: 6022005217
e-mail: jkrakoff@mail.nih.gov

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Clifton Bogardus, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00339833     History of Changes
Other Study ID Numbers: 999903121
03-DK-N121 ( Other Identifier: National Institutes of Health Clinical Center )
03-DK-N121 ( Other Identifier: NIHCC )
First Submitted: June 19, 2006
First Posted: June 21, 2006
Results First Submitted: December 29, 2010
Results First Posted: March 6, 2013
Last Update Posted: March 6, 2013