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The possibility that obesity-associated inflammatory changes may play a role in the pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that salicylates might represent a useful treatment to improve glucose tolerance. Several studies, performed in patients with 2DM, as well as in nondiabetic, obese individuals, have demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but have not led to a coherent view as to the mechanism(s) involved.
In this research proposal we will use specific methods to quantify insulin mediated glucose uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers to identify those individuals who are sufficiently insulin resistant to be enrolled in this study. We will then use the graded glucose infusion technique in these insulin resistant subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline measurements, salsalate or placebo will be administered for one month to the participants, after which time the IST and the graded glucose infusion will be repeated to quantify and compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus placebo. These results will provide for the first time quantitative data of the effect of salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| salsalate 3500mg in 2 divided doses a day | Active Comparator | Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner |
|
| placebo | Placebo Comparator | Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salsalate | Drug | Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of Insulin Action With the Insulin Suppression Test (IST) | Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group | after treatment for one month |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT) | compare changes in insulin clearance as assessed by the GGIT before and after treatment with salsalate to placebo | one month on treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerald M Reaven, M.D. | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24963111 | Derived | Kim SH, Liu A, Ariel D, Abbasi F, Lamendola C, Grove K, Tomasso V, Ochoa H, Reaven G. Effect of salsalate on insulin action, secretion, and clearance in nondiabetic, insulin-resistant individuals: a randomized, placebo-controlled study. Diabetes Care. 2014 Jul;37(7):1944-50. doi: 10.2337/dc13-2977. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Salsalate 3500mg in 2 Divided Doses a Day | Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner |
| FG001 | Placebo | Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Salsalate 3500mg in 2 Divided Doses a Day | Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quantification of Insulin Action With the Insulin Suppression Test (IST) | Compare changes in insulin sensitivity as assesses by the IST before and after treatment between salsalate and placebo group | Posted | Median | 95% Confidence Interval | mmol/L | after treatment for one month |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Salsalate 3500mg in 2 Divided Doses a Day | Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 3 years | Gastrointestinal disorders | Systematic Assessment | heartburn |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gerald Reaven | Stanford Universtiy | 650-724-3416 | greaven@stanford.edu |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C014182 | salicylsalicylic acid |
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| Placebo | Drug | Participants will take 3 tablets with breakfast and 4 tablets with dinner |
|
Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Quantification of Insulin Clearance With the Graded Glucose Infusion Test (GGIT) | compare changes in insulin clearance as assessed by the GGIT before and after treatment with salsalate to placebo | Posted | Median | 95% Confidence Interval | pmol/min x 4h | one month on treatment |
|
|
|
| 0 |
| 27 |
| 1 |
| 27 |
| EG001 | Placebo | Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner | 0 | 14 | 0 | 14 |
| tinnitus | Ear and labyrinth disorders | Systematic Assessment |
|
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