A Biomarker to Detect Salt Sensitivity

NCT03147170 | Completed

• 1 other identifier: 1512M81431
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are proposing that individuals with elevated levels of NT-proBNP are resistant to natriuretic peptides and are unable to handle sodium loads and maintain optimal blood pressure values.The investigators will test this hypothesis by comparing the blood pressure response to low and high salt diets in individuals with pre- or hypertension and who have normal or elevated levels of NT-proBNP. The investigators expect that blood pressure values in those with normal levels of NT-proBNP will not change with high salt diets, whereas, in those with elevated levels of NT-proBNP, blood pressure values will increase significantly when exposed to high salt diets.

Conditions

Hypertension Uncomplicated; Pre Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in blood pressure

  Difference in blood pressure before and after diets periods and comparison between those with normal and elevated blood levels of NT-proBNP.

  9 weeks

Secondary Outcomes (1)

• Ratio of BNP/cGMP

  9 weeks

Interventions

High and low salt diets DIAGNOSTIC_TEST

Effects of high and low salt diets on blood pressure in individuals with normal and elevated levels of NT-proBNP

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pre- or hypertensive individuals without chronic complications, between the ages of 30 and 75 years, not on blood pressure lowering medications.

You may qualify if:

• Systolic blood pressure \> 120 and \< 160 mmHg
• Diastolic blood pressure \> 80 and \< 100 mmHg
• Not on hypertensive medications
• NT-proBNP between 40 - 99 pg/mL (healthy levels)
• NT-proBNP \> 120 pg/mL (elevated levels)

You may not qualify if:

• Physician reported diabetes or on insulin or oral hypoglycemic agents
• BMI \> 40kg/m2
• Age \< 30 or \> 75 years
• Presence of cardiovascular disease or chronic kidney disease
• Chronic obstructive pulmonary disease or pulmonary arterial hypertension
• Aldosterone secreting disorder
• Estimated energy intake greater than 3400 calories
• Pregnancy
• Individuals with pacemakers

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Prehypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Otto A Sanchez, MD PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: January 1, 2016
• Primary Completion: June 30, 2018
• Study Completion: December 31, 2018
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (1)