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The Study of Inflammation on Blood Glucose Levels in Obese People
This study has been completed.
Sponsors and Collaborators: Joslin Diabetes Center
National Institutes of Health (NIH)
Information provided by: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00258115
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: salsalate
Phase II

MedlinePlus related topics: Diabetes Obesity
Drug Information available for: Dextrose Salicylsalicylic acid Sodium salicylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Study of Inhibition of Inflammation in the Dysmetabolic Syndrome of Obesity

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • glycemia

Estimated Enrollment: 20
Study Start Date: December 2003
  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258115

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Investigators
Principal Investigator: Allison B. Goldfine, MD Investigator/Assistant Professor
  More Information

Joslin Diabetes Center Web-Site  This link exits the ClinicalTrials.gov site
Multicenter study to target inflammation using salsalate in type 2 diabetes.  This link exits the ClinicalTrials.gov site

Publications of Results:
Other Publications:
Study ID Numbers: CHS 03-48
Study First Received: November 22, 2005
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00258115  
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:
Obesity
Metabolic Syndrome
Diabetes
Inflammation

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Salicylsalicylic acid
Sodium Salicylate
Diabetes Mellitus
Nutrition Disorders
Overweight
Overnutrition
Inflammation

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009