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OpenTrials
Completed

NCT Number: NCT00258115

The Study of Inflammation on Blood Glucose Levels in Obese People

Chronic subaccute inflammation may underlie the development of diabetes cardiovascular disease and other components of the metabolic syndrome. Rodent studies suggest diet induced obesity is associated with activation of the IKK/NF-kB pathway and this pathway can be inhibited by salicylates. This study seeks to determine the effect of salicylates in overweight persons.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • obesity (> 85th% for age,BMI > 30); HbA1c <6%; hemoglobin and/or hematocrit within 2 standard deviations of normal range, without high risk of bleeding, without donation of blood in the previous 2 months; without involvement in any study evaluating an investigational drug or device for the previous 2 months; normal clotting studies; if female using barrier or oral contraception and with a negative pregnancy test.

Exclusion criteria

  • Pregnant or lactating women; Patients with abnormal liver function defined as elevation of bilirubin, alkaline phosphatase, ALT, AST, or GGTP more than 1.5 times the upper limit of normal; Patients with kidney disease (serum creatinine > 1.5 mg/dL) macroalbuminuria (1+ protein on a standard urine dip-stick, or > 300 mg urinary albumin/day); (patients with microalbuminuria will be enrolled); Patients with any significant diseases or conditions, including emotional or psychiatric disorders and substance abuse, including history of binge drinking, that, in the opinion of the investigator, are likely to alter the patient's ability to complete the study ; Patients with metabolic acidosis (abnormal anion gap); History of gastric ulcer, dyspepsia, or upper or lower GI bleed; History of allergy to aspirin, or bleeding diathesis or currently on oral anticoagulants including warfarin, heparin, aspirin or other NSAIDs; Patients with major vascular event within 6 months of screening for the study (e.g., MI, stroke, CABG, angioplasty, PV surgery); Patients with chronic heart disease, or a history of myocardial infarction or stroke. Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA; classification as Functional Class III or IV; Patients who smoke more than one pack of cigarettes daily; Patients taking treatment medications known to affect insulin sensitivity (e.g. diuretics, beta-blockers); Patients with inadequately controlled serum lipid levels (total cholesterol ≥ 275 mg/dL and fasting triglycerides ≥ 450 mg/dL); Patients with history of cancer within 5 years prior to screening for the study other than basal cell carcinoma; active alcohol or other substance abuse.

Treatment and study plan

Salsalate

Drug

Primary outcomes

  1. glycemia

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

The Study of Inhibition of Inflammation in the Dysmetabolic Syndrome of Obesity

Important dates

Study start
2003
Primary completion
2007
First posted
Nov 24, 2005
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.