Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079690
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2004-03-10
Brief Title:
Genetic Epidemiology of Blood Pressure Intervention
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-05
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 localize and identify new genes related to variation in blood pressure BP responses to a low dietary sodium intake a high dietary sodium intake oral potassium supplementation and the cold pressor test
Detailed Description:
BACKGROUND
Systemic hypertension is a complex disease determined by both genetic and environmental factors and is of significant public health interest In addition identifying genes that interact significantly with dietary sodium and potassium intake or even the cold pressure test may enable clinicians to target life style modification for prevention and treatment of hypertension
The study is conducted in response to a Request for Applications issued in October 2001 on the Interaction of Genes and the Environment in Shaping Risk Factors for Heart Lung Blood and Sleep Disorders
DESIGN NARRATIVE
The study uses a family intervention study design The investigators will recruit 750 sibships n1750 siblings and their parents n1250 from 500 families each family ascertained through a proband who has untreated high normal BP or stage-1 hypertension systolic BP 130-160 mm Hg and diastolic BP 85-100 mm Hg from rural China They will collect baseline information on medical history lifestyle risk factors anthropometric measures BP and blood measures renin activity ACE angiotensin II natriuretic peptide glucose insulin and lipids in all participants and dietary nutrient intake three 24-hour recalls and urinary sodium and potassium excretion three 24-hour in the siblings They will conduct the following interventions in the siblings a cold pressor test at baseline day 2 or 3 a 1-week low sodium-feeding study 40 mmol sodiumday on days 4-10 a 1-week high sodium-feeding study 280 mmol sodiumday on days 11-17 and a 1-week oral potassium supplementation 90 mmol potassiumday on days 18-24 They will measure BP and 24-hour urinary sodium and potassium excretion during the last 3 days of each intervention period They will also perform genotyping for genomewide linkage scans and for candidate genes in all siblings and their parents BP responses to the interventions will be analyzed primarily as quantitative traits The primary analyses include linkage analysis transmissiondisequilibrium test and association analysis between genetic markers and BP responses to the interventions
Systemic hypertension is a complex disease determined by both genetic and environmental factors and is of significant public health interest In addition identifying genes that interact significantly with dietary sodium and potassium intake or even the cold pressure test may enable clinicians to target life style modification for prevention and treatment of hypertension
The study is conducted in response to a Request for Applications issued in October 2001 on the Interaction of Genes and the Environment in Shaping Risk Factors for Heart Lung Blood and Sleep Disorders
DESIGN NARRATIVE
The study uses a family intervention study design The investigators will recruit 750 sibships n1750 siblings and their parents n1250 from 500 families each family ascertained through a proband who has untreated high normal BP or stage-1 hypertension systolic BP 130-160 mm Hg and diastolic BP 85-100 mm Hg from rural China They will collect baseline information on medical history lifestyle risk factors anthropometric measures BP and blood measures renin activity ACE angiotensin II natriuretic peptide glucose insulin and lipids in all participants and dietary nutrient intake three 24-hour recalls and urinary sodium and potassium excretion three 24-hour in the siblings They will conduct the following interventions in the siblings a cold pressor test at baseline day 2 or 3 a 1-week low sodium-feeding study 40 mmol sodiumday on days 4-10 a 1-week high sodium-feeding study 280 mmol sodiumday on days 11-17 and a 1-week oral potassium supplementation 90 mmol potassiumday on days 18-24 They will measure BP and 24-hour urinary sodium and potassium excretion during the last 3 days of each intervention period They will also perform genotyping for genomewide linkage scans and for candidate genes in all siblings and their parents BP responses to the interventions will be analyzed primarily as quantitative traits The primary analyses include linkage analysis transmissiondisequilibrium test and association analysis between genetic markers and BP responses to the interventions
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL072507 | NIH | None | httpsreporternihgovquickSearchU01HL072507 |