Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005187
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2000-05-25
Brief Title:
Cardiovascular Risk Profile Among Mexican-Americans
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2019-04
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:
To characterize the epidemiology and genetics of apolipoproteins A-I A-II B C-II C-III and E in a population of Mexican-Americans in Starr County Texas
Detailed Description:
BACKGROUND
Evidence has established that the distribution and burden of several common chronic diseases among Mexican-Americans differ from that in the general population These diseases include diabetes almost exclusively noninsulin dependent diabetes hypertension and gallbladder disorders While progress was made towards an elucidation of their epidemiology within this population there was a paucity of data regarding other cardiovascular risk factors most notably the distribution of lipoproteins and their constituent apoproteins With regard to the apolipoproteins there were only minimal data from any population dealing with their distribution and relationships in the general population or pedigrees This project provided as complete a profile on the distribution of metabolic cardiovascular risk factors as could be claimed for any other study of comparable size and provided baseline values for apo A-I A-II B C-II C-III and E
DESIGN NARRATIVE
One thousand randomly selected individuals were given a complete physical examination From those 1000 100 probands with gallbladder disease were selected Approximately 1200 first degree relatives of the probands were invited to participate in the study and given a physical examination Additionally 100 control individuals their spouses and first degree relatives were followed longitudinally for five years Blood samples were obtained for determination of total cholesterol LDL cholesterol HDL2 and HDL3 cholesterol and genetic markers Data were collected on age sex body mass and fat distribution diet smoking and alcohol consumption Annual follow-up assessed the dynamics of changes in apolipoprotein levels and profiles and those factors which contributed to their change The random and longitudinal data were combined with pedigree data to determine the effects of major genes polygenes and the environment on the variability of each apolipoprotein and on the relationship between these and other risk factors An assessment was made in 100 individuals of the contribution of genetic variability at the DNA level in determining apolipoprotein levels
Evidence has established that the distribution and burden of several common chronic diseases among Mexican-Americans differ from that in the general population These diseases include diabetes almost exclusively noninsulin dependent diabetes hypertension and gallbladder disorders While progress was made towards an elucidation of their epidemiology within this population there was a paucity of data regarding other cardiovascular risk factors most notably the distribution of lipoproteins and their constituent apoproteins With regard to the apolipoproteins there were only minimal data from any population dealing with their distribution and relationships in the general population or pedigrees This project provided as complete a profile on the distribution of metabolic cardiovascular risk factors as could be claimed for any other study of comparable size and provided baseline values for apo A-I A-II B C-II C-III and E
DESIGN NARRATIVE
One thousand randomly selected individuals were given a complete physical examination From those 1000 100 probands with gallbladder disease were selected Approximately 1200 first degree relatives of the probands were invited to participate in the study and given a physical examination Additionally 100 control individuals their spouses and first degree relatives were followed longitudinally for five years Blood samples were obtained for determination of total cholesterol LDL cholesterol HDL2 and HDL3 cholesterol and genetic markers Data were collected on age sex body mass and fat distribution diet smoking and alcohol consumption Annual follow-up assessed the dynamics of changes in apolipoprotein levels and profiles and those factors which contributed to their change The random and longitudinal data were combined with pedigree data to determine the effects of major genes polygenes and the environment on the variability of each apolipoprotein and on the relationship between these and other risk factors An assessment was made in 100 individuals of the contribution of genetic variability at the DNA level in determining apolipoprotein levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| R01HL034823 | NIH | None | httpsreporternihgovquickSearchR01HL034823 |