The Study of Inflammation on Blood Glucose Levels in Obese People



Status:Completed
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 30
Updated:2/17/2018
Start Date:December 2003

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

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.


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.
We found this trial at
1
site
One Joslin Place
Boston, Massachusetts 02215
617-309-2400
Joslin Diabetes Center Joslin Diabetes Center, located in Boston, Massachusetts, is the world's largest diabetes...
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Boston, MA
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