The Study of Inflammation on Blood Glucose Levels in Obese People
Sponsor
Joslin Diabetes Center (Other)
Overall Status
Completed
CT.gov ID
NCT00258115
Collaborator
National Institutes of Health (NIH) (NIH)
20
1
2
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Study of Inhibition of Inflammation in the Dysmetabolic Syndrome of Obesity
Study Start Date
:
Dec 1, 2003
Actual Primary Completion Date
:
Oct 1, 2007
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: salsalate 4.0 g/d divided dosing |
Drug: salsalate
|
Placebo Comparator: placebo placebo for salsalate |
Drug: salsalate
|
Outcome Measures
Primary Outcome Measures
- glycemia [one month]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Joslin Diabetes Center | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Joslin Diabetes Center
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Allison B. Goldfine, MD, Investigator/Assistant Professor
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Goldfine AB, Silver R, 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. Clin Transl Sci. 2008 May;1(1):36-43. doi: 10.1111/j.1752-8062.2008.00026.x.
- Shoelson SE, Lee J, Goldfine AB. Inflammation and insulin resistance. J Clin Invest. 2006 Jul;116(7):1793-801. Review. Erratum in: J Clin Invest. 2006 Aug;116(8):2308.
Responsible Party:
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT00258115
Other Study ID Numbers:
- CHS 03-48
First Posted:
Nov 24, 2005
Last Update Posted:
Feb 15, 2018
Last Verified:
Feb 1, 2018
Keywords provided by Joslin Diabetes Center
Additional relevant MeSH terms: