The Study of Inflammation on Blood Glucose Levels in Obese People
This study has been completed.
Sponsor:
Joslin Diabetes Center
Collaborator:
Information provided by (Responsible Party):
Allison Goldfine, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00258115
First received: November 22, 2005
Last updated: September 21, 2012
Last verified: September 2012
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | The Study of Inhibition of Inflammation in the Dysmetabolic Syndrome of Obesity |
Resource links provided by NLM:
Further study details as provided by Joslin Diabetes Center:
Primary Outcome Measures:
- glycemia [ Time Frame: one month ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | December 2003 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: salsalate
4.0 g/d divided dosing
|
Drug: salsalate |
|
Placebo Comparator: placebo
placebo for salsalate
|
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
Additional Information:
Publications:
Goldfine AB, Silver S, Aldhahi W, Cai D, Tatro E, Lee J, Shoelson SE. Use of Salsalate to Target Inflammation in the Treatment of Insulin Resistance and Type 2 Diabetes, Clinical and Translational Science, 2008 May;1(1):36-43
| Responsible Party: | Allison Goldfine, Investigator, Joslin Diabetes Center |
| ClinicalTrials.gov Identifier: | NCT00258115 History of Changes |
| Other Study ID Numbers: | CHS 03-48 |
| Study First Received: | November 22, 2005 |
| Last Updated: | September 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Joslin Diabetes Center:
|
Obesity Metabolic Syndrome Diabetes Inflammation |
Additional relevant MeSH terms:
|
Inflammation Obesity Pathologic Processes Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Sodium Salicylate Salicylsalicylic acid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013