Ignite Creation Date:
2024-05-05 @ 10:47 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01182727
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2010-08-13
Brief Title:
Salsalate for Insulin Resistance in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Salsalate for the Treatment of Insulin Resistance in People With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Being obese is a common problem for people with schizophrenia People with schizophrenia are more likely to be overweight compared to the general population Being overweight is a major risk factor for developing type II diabetes Approximately 15 of people with schizophrenia have type II diabetes People with type II diabetes have problems with their bodys insulin Insulin is a hormone produced by the body to control blood sugar level Obesity and type II diabetes are strong risk factors for heart disease In type II diabetes the body does not respond to insulin correctly Obesity type II diabetes and insulin resistance are all common states of inflammation Inflammation is a reaction by the body to irritation injury or infection
Salicylates are non-steroidal anti-inflammatory drugs Aspirin is an example of a salicylate These drugs work by decreasing the level of inflammation in the body Salicylates have been shown to decrease inflammation and improve the bodys response to insulin Improving the bodys response to insulin and decreasing inflammation could possibly reduce the risk of developing type II diabetes Salicylates have been known for years to be effective for the treatment of diabetes Salicylates increase the bodys response to insulin causing blood sugar levels to decrease Many salicylate drugs have side effects including stomach irritation and increased risk of bleeding The drug for this study is called salsalate and is different from other salicylates Salsalate has a lower bleeding risk than aspirin Salsalate has been used to treat arthritis and has been shown to be safe
There have been no studies using salsalate in people with schizophrenia The purpose of this study is to gain experience in the use of salsalate in people with schizophrenia The study would be a pilot study to obtain preliminary data The study would be a 6-week study where everyone in the study would receive the drug salsalate The participants in the study will have tests of baseline symptoms of schizophrenia a physical exam EKG to check heart function and a side effect checklist for possible side effects from salsalate The study will also have some blood drawn to measure blood sugar levels insulin levels and inflammatory markers
Salicylates are non-steroidal anti-inflammatory drugs Aspirin is an example of a salicylate These drugs work by decreasing the level of inflammation in the body Salicylates have been shown to decrease inflammation and improve the bodys response to insulin Improving the bodys response to insulin and decreasing inflammation could possibly reduce the risk of developing type II diabetes Salicylates have been known for years to be effective for the treatment of diabetes Salicylates increase the bodys response to insulin causing blood sugar levels to decrease Many salicylate drugs have side effects including stomach irritation and increased risk of bleeding The drug for this study is called salsalate and is different from other salicylates Salsalate has a lower bleeding risk than aspirin Salsalate has been used to treat arthritis and has been shown to be safe
There have been no studies using salsalate in people with schizophrenia The purpose of this study is to gain experience in the use of salsalate in people with schizophrenia The study would be a pilot study to obtain preliminary data The study would be a 6-week study where everyone in the study would receive the drug salsalate The participants in the study will have tests of baseline symptoms of schizophrenia a physical exam EKG to check heart function and a side effect checklist for possible side effects from salsalate The study will also have some blood drawn to measure blood sugar levels insulin levels and inflammatory markers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None