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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Clifton Bogardus, National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00339833
First received: June 19, 2006
Last updated: January 29, 2013
Last verified: January 2013
Results First Received: December 29, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
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
  Description
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  
NOT COMPLETED     6     8  
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
  Description
Salsalate Salsalate (3g/day) for 7 days
Placebo Identical placebo for 7 days
Total Total of all reporting groups

Baseline Measures
    Salsalate     Placebo     Total  
Number of Participants  
[units: participants]
  22     18     40  
Age  
[units: years]
Mean ± Standard Deviation
  29  ± 7     33  ± 8     31  ± 7.5  
Gender  
[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  
BMI  
[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 )
  80  
  ( 56 to 104 )  
  63  
  ( 49 to 90 )  
  76  
  ( 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 )
  13  
  ( 11 to 15 )  
  16  
  ( 13 to 20 )  
  14  
  ( 11 to 20 )  



  Outcome Measures
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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:
Publications automatically indexed to this study:

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, 03-DK-N121
Study First Received: June 19, 2006
Results First Received: December 29, 2010
Last Updated: January 29, 2013
Health Authority: United States: Federal Government