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

History of Changes

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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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 ]

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2. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
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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:

Vozarova B, Weyer C, Hanson K, Tataranni PA, Bogardus C, Pratley RE. Circulating interleukin-6 in relation to adiposity, insulin action, and insulin secretion. Obes Res. 2001 Jul;9(7):414-7.

Pratley RE, Wilson C, Bogardus C. Relation of the white blood cell count to obesity and insulin resistance: effect of race and gender. Obes Res. 1995 Nov;3(6):563-71.

Pickup JC, Crook MA. Is type II diabetes mellitus a disease of the innate immune system? Diabetologia. 1998 Oct;41(10):1241-8. Review.

Publications automatically indexed to this study:

Koska J, Ortega E, Bunt JC, Gasser A, Impson J, Hanson RL, Forbes J, de Courten B, Krakoff J. The effect of salsalate on insulin action and glucose tolerance in obese non-diabetic patients: results of a randomised double-blind placebo-controlled study. Diabetologia. 2009 Mar;52(3):385-93. Epub 2008 Dec 23.

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

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