Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122447
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2005-07-21
Brief Title:
Cardiovascular Disease CVD Risk and Prevention in Early Glucose Intolerance
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
CVD Risk and Prevention in Early Glucose Intolerance
Status:
COMPLETED
Status Verified Date:
2013-11
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:
The purpose of this study is to determine whether cardiovascular disease CVD risk markers β-cell function and insulin sensitivity can be improved by targeting mechanisms of both diabetes and CVD - using an antioxidant an angiotensin II receptor blocker ARB or an anti-inflammatory agent - in patients with impaired glucose tolerance IGT in a randomized controlled trial
Detailed Description:
Diabetes is a common major health problem in the United States and it significantly increases the risk of developing heart disease which is the leading cause of death Research studies have shown that the risk of heart disease is increased even in the pre-diabetes or impaired glucose tolerance IGT stage before the onset of true diabetes While many studies have shown that aggressive management of diabetes lowers the risk of heart disease at the present time it is not known how best to treat patients with impaired glucose tolerance pre-diabetes to prevent the development of heart disease It is also not known where in the range of blood sugar levels risk begins to increase The purpose of this study is to determine
whether medications which target pathways involved in the development of heart disease can decrease the risk of heart disease in individuals with impaired glucose tolerance and
whether a high blood sugar level measured one hour after drinking a standard high-sugar drink is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes
The purpose of Aim 1 of this study is to determine whether medications which target pathways involved in the development of heart disease can decrease the risk of heart disease in individuals with impaired glucose tolerance One hundred-twenty volunteers with impaired glucose tolerance and 30 volunteers with normal glucose tolerance normal blood sugars after ingesting a standard high-sugar drink will be recruited from the Screening for Impaired Glucose Tolerance SIGT study The 30 volunteers with normal glucose tolerance will not take any study medication but will undergo medical testing to determine their risk of heart disease at the beginning of the study after which their participation in the study will be complete The 120 volunteers with impaired glucose tolerance will be randomly assigned to one of four medications to be taken over a one-year period
alpha lipoic acid an antioxidant dietary supplement
olmesartan a drug used to treat high blood pressure
aspirin an anti-inflammatory drug and
placebo an inactive dummy pill
Subjects with impaired glucose tolerance will undergo medical testing to determine their risk of heart disease at the beginning of the study before beginning study medications after 3 months of intervention and again at the end of the study 12 months after enrollment Test results will be compared between the subjects taking each of the active medications and those taking placebo to determine if the medications lead to a significant reduction in the risk for the development of heart disease The medical tests used in this study are currently used in medical practice and include blood and urine specimens ultrasound testing of the artery at the arm and an insulin sensitivity test test of how effectively the body uses sugar All visits and tests will be conducted in the General Clinical Research Centers of Emory University Hospital and Grady Memorial Hospital
The purpose of Aim 2 of this study is to determine whether a high blood sugar level measured one hour after drinking a standard high-sugar drink 1-hour blood sugar level is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes Seventy-five volunteers with normal glucose tolerance normal blood sugars after ingesting a standard high-sugar drink will be recruited from the SIGT study as well as 15 subjects with impaired glucose tolerance and 15 with diabetes The subjects with normal glucose tolerance will be grouped into those with low middle and high 1-hour blood sugar levels All subjects will undergo medical testing as in Aim 1 above to determine their risk of heart disease Test results of subjects with low middle and high 1-hour blood sugar levels will be compared against one another as well as against those of subjects with IGT and diabetes If subjects with normal glucose tolerance but high 1-hour blood sugar levels are found to have increased risk for heart disease compared to those with low 1-hour blood sugar levels then the 1-hour blood sugar levels may provide important information regarding an increased risk of heart disease even in individuals with normal glucose tolerance but high 1-hour blood sugar levels - a population which otherwise would not be identified with the current standard tests used for the diagnosis of diabetes and pre-diabetes
Over 40 million Americans have pre-diabetes impaired glucose tolerance which is associated with an increased risk of the development of both diabetes and heart disease Findings from these studies will provide important insights into the pathways that lead to the development of heart disease related to pre-diabetes prevention of heart disease in the pre-diabetic population and identification of individuals at high risk for heart disease earlier in their natural history - even before the onset of pre-diabetes
whether medications which target pathways involved in the development of heart disease can decrease the risk of heart disease in individuals with impaired glucose tolerance and
whether a high blood sugar level measured one hour after drinking a standard high-sugar drink is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes
The purpose of Aim 1 of this study is to determine whether medications which target pathways involved in the development of heart disease can decrease the risk of heart disease in individuals with impaired glucose tolerance One hundred-twenty volunteers with impaired glucose tolerance and 30 volunteers with normal glucose tolerance normal blood sugars after ingesting a standard high-sugar drink will be recruited from the Screening for Impaired Glucose Tolerance SIGT study The 30 volunteers with normal glucose tolerance will not take any study medication but will undergo medical testing to determine their risk of heart disease at the beginning of the study after which their participation in the study will be complete The 120 volunteers with impaired glucose tolerance will be randomly assigned to one of four medications to be taken over a one-year period
alpha lipoic acid an antioxidant dietary supplement
olmesartan a drug used to treat high blood pressure
aspirin an anti-inflammatory drug and
placebo an inactive dummy pill
Subjects with impaired glucose tolerance will undergo medical testing to determine their risk of heart disease at the beginning of the study before beginning study medications after 3 months of intervention and again at the end of the study 12 months after enrollment Test results will be compared between the subjects taking each of the active medications and those taking placebo to determine if the medications lead to a significant reduction in the risk for the development of heart disease The medical tests used in this study are currently used in medical practice and include blood and urine specimens ultrasound testing of the artery at the arm and an insulin sensitivity test test of how effectively the body uses sugar All visits and tests will be conducted in the General Clinical Research Centers of Emory University Hospital and Grady Memorial Hospital
The purpose of Aim 2 of this study is to determine whether a high blood sugar level measured one hour after drinking a standard high-sugar drink 1-hour blood sugar level is associated with an increased risk of heart disease even in individuals who have no evidence of diabetes or pre-diabetes Seventy-five volunteers with normal glucose tolerance normal blood sugars after ingesting a standard high-sugar drink will be recruited from the SIGT study as well as 15 subjects with impaired glucose tolerance and 15 with diabetes The subjects with normal glucose tolerance will be grouped into those with low middle and high 1-hour blood sugar levels All subjects will undergo medical testing as in Aim 1 above to determine their risk of heart disease Test results of subjects with low middle and high 1-hour blood sugar levels will be compared against one another as well as against those of subjects with IGT and diabetes If subjects with normal glucose tolerance but high 1-hour blood sugar levels are found to have increased risk for heart disease compared to those with low 1-hour blood sugar levels then the 1-hour blood sugar levels may provide important information regarding an increased risk of heart disease even in individuals with normal glucose tolerance but high 1-hour blood sugar levels - a population which otherwise would not be identified with the current standard tests used for the diagnosis of diabetes and pre-diabetes
Over 40 million Americans have pre-diabetes impaired glucose tolerance which is associated with an increased risk of the development of both diabetes and heart disease Findings from these studies will provide important insights into the pathways that lead to the development of heart disease related to pre-diabetes prevention of heart disease in the pre-diabetic population and identification of individuals at high risk for heart disease earlier in their natural history - even before the onset of pre-diabetes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23DK070715-01A1 | NIH | Daiichi Sankyo | httpsreporternihgovquickSearch1K23DK070715-01A1 |
| UL1RR025008 | NIH | None | None |
| Sankyo CS-866 | OTHER | None | None |