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Analyzing Genetic Factors Involved in Blood Pressure Changes Due to Salt and Potassium Intake (The GenSalt Study)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00721721
First received: July 22, 2008
Last updated: August 29, 2008
Last verified: August 2008
  Purpose

High blood pressure is a serious health problem. In terms of diet recommendations, people with this condition are encouraged to eat a low sodium and high potassium diet. It is believed that genetics may play a role in the development of high blood pressure and may affect changes in blood pressure levels, including changes brought on by sodium and potassium. This study will identify genetic factors that may influence blood pressure changes due to increased salt or potassium intake in people with mildly elevated blood pressure and in their family members.


Condition Intervention Phase
Blood Pressure
Behavioral: Low Sodium Diet
Behavioral: High Sodium Diet
Dietary Supplement: Potassium Supplementation
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Genetic Epidemiology Network of Salt Sensitivity

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Blood pressure [ Time Frame: Measured at Day 21 ] [ Designated as safety issue: No ]

Enrollment: 1906
Study Start Date: October 2003
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will follow a low sodium diet for Days 1 through 7, a high sodium diet for Days 7 through 14, and a high sodium diet plus potassium supplement regimen for Days 14 through 21.
Behavioral: Low Sodium Diet
3 grams of salt or 51.3 mmol of sodium per day
Behavioral: High Sodium Diet
18 grams of salt or 307.8 mmol of sodium per day
Dietary Supplement: Potassium Supplementation
60 mmol potassium supplement

Detailed Description:

High blood pressure is one of the most common health problems among adults. If left untreated, it can lead to heart failure, kidney failure, or stroke. Common causes include stress, diet, diabetes, kidney disease, or obesity. Typical treatments include taking medication, losing weight, and quitting smoking. It is also recommended that people with high blood pressure or those at risk of developing high blood pressure modify their diets to decrease sodium intake and increase potassium intake. Research has shown that genetics may play a role in the development of high blood pressure and may affect fluctuations of blood pressure levels, including blood pressure changes brought on by sodium and potassium. This study will identify and analyze the genetic factors that may be responsible for blood pressure changes due to dietary salt and potassium intake. Blood samples collected in this study may also be used for future genetic research on blood pressure.

This study will enroll people who have mildly elevated blood pressure and their siblings, spouses, and children. Participants will first take part in a 3-day observation period. At a Day 1 study visit, participants' weight, height, waist size, and blood pressure will be measured. There will be three separate blood pressure measurements. Study staff will then interview participants to collect information on family and personal medical history, cigarette smoking habits, alcohol consumption, physical activity, and diet. Finally, blood samples will be collected. For 24 hours after the first study visit, participants will collect their urine. At study visits on Days 2 and 3, participants will undergo three blood pressure measurements and a cold pressor test, which measures blood pressure at different body temperatures. Participants will also collect a urine sample each night.

After the 3-day observation period, participants will take part in a 3-week treatment period. Each day, all participants will eat breakfast, lunch, and dinner in the study kitchen. For Days 1 through 7, participants will eat a low sodium diet; for Days 7 through 14, participants will eat a high sodium diet; and for Days 14 through 21, participants will eat a high sodium diet and receive potassium supplements. Blood pressure will be measured three times per day and urine will be collected at several times during this period. Blood samples will be collected at the end of each week.

Parents of participants will also be enrolled in this study, and they will complete the same study procedures that participants complete during the 3-day observation period except for the urine collection.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria for Primary Participants:

  • Between 18 and 60 years old
  • Systolic blood pressure level of 130 to 160 mm Hg and/or diastolic blood pressure level of 85 to 100 mm Hg
  • Both parents (2-generation nuclear family) or at least one parent (at least a 3-generation family) is available and willing to participate in the study
  • At least one sibling meets eligibility criteria for participation

Inclusion Criteria for Sibling/Spouse/Child Participants:

  • Siblings and spouses must be between 18 and 60 years old; children must be more than 16 years old
  • Lives in the same village as the main study participant

Exclusion Criteria for All Participants:

  • Current stage 2 hypertension (systolic blood pressure level greater than or equal to 160 mm Hg and/or diastolic blood pressure level greater than or equal to 100 mm Hg)
  • Current or recent (i.e., less than 1 month before the screening visit) use of antihypertensive medications or medications that affect blood pressure
  • Secondary hypertension
  • History of clinical cardiovascular disease, including heart attack, congestive heart failure, stroke, and peripheral arterial disease
  • Chronic kidney failure or urinary albumin concentration of greater than or equal to 20 mg/dL
  • Current diabetes (i.e., fasting serum glucose level greater than or equal to 126 mg/dL) or use of insulin or oral hypoglycemic agents
  • Peptic ulcer disease requiring treatment in the 2 years before study entry
  • Liver disease requiring treatment in the 2 years before study entry
  • Pregnant
  • Heavy alcohol drinker (i.e., more than 14 drinks per week)
  • Currently adhering to a low sodium diet
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721721

Locations
China
Chinese Academy of Medical Sciences
Beijing, China
Sponsors and Collaborators
Investigators
Principal Investigator: Jiang He, MD, PhD Tulane University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jiang He, MD, PhD, Tulane University
ClinicalTrials.gov Identifier: NCT00721721     History of Changes
Other Study ID Numbers: 1412, U01 HL072507
Study First Received: July 22, 2008
Last Updated: August 29, 2008
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Dietary Sodium
Dietary Potassium
Genes
Genomics

ClinicalTrials.gov processed this record on November 20, 2014