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Sponsors and Collaborators: |
Joslin Diabetes Center National Institutes of Health (NIH) |
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Information provided by: | Joslin Diabetes Center |
ClinicalTrials.gov Identifier: | NCT00258128 |
We believe that diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway and that chronic inflammation leads to insulin resistance and diabetes. In rodents, salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is true in people.
Condition | Intervention | Phase |
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Insulin Resistance |
Drug: salicylate |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Effect of Salicylate on Glucose Metabolism in Insulin Resistance States |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
age 18 to 65 years, inclusive; HbA1c >6.0% (off medication-diabetic) normal hemoglobin and hematocrit, 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; female postmenopausal or surgically sterile, or using barrier or oral contraception and with a negative pregnancy test.
Exclusion Criteria:
pregnant or lactating women; patients with persistent ketonuria or a history of ketoacidosis (suggesting the need for insulin therapy); current of previous use of insulin for glucose control; 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., myocardial infarction stroke, coronary artery bypass graft (CABG) surgery, angioplasty, peripheral vascular 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 with HbA1C > 13% (normal range 4-6%); 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 taking warfarin, heparin or NSAID on a chronic basis; 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.
Study ID Numbers: | CHS 00-01 |
Study First Received: | November 22, 2005 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00258128 History of Changes |
Health Authority: | United States: Institutional Review Board |
Anti-Inflammatory Agents Metabolic Diseases Cyclooxygenase Inhibitors Salicylates Insulin Hyperinsulinism Analgesics, Non-Narcotic |
Anti-Inflammatory Agents, Non-Steroidal Insulin Resistance Analgesics Peripheral Nervous System Agents Glucose Metabolism Disorders Antirheumatic Agents Metabolic Disorder |
Anti-Inflammatory Agents Metabolic Diseases Molecular Mechanisms of Pharmacological Action Cyclooxygenase Inhibitors Physiological Effects of Drugs Salicylates Enzyme Inhibitors Pharmacologic Actions Hyperinsulinism Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Insulin Resistance Analgesics Peripheral Nervous System Agents Antirheumatic Agents Glucose Metabolism Disorders Central Nervous System Agents |