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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005249
Other study ID # 1131
Secondary ID R01HL039748
Status Completed
Phase N/A
First received May 25, 2000
Last updated May 12, 2016
Start date September 1989
Est. completion date August 1991

Study information

Verified date April 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

To determine the roles of insulin, lipids, body weight and ion transport in blood pressure regulation.


Description:

BACKGROUND:

Insulin levels are consistently related to blood pressure, obesity, and blood lipids. Insulin level correlation with sodium-lithium countertransport is limited to only one available study done in white, normotensive, predominantly normal weight women aged 45-52. The relationship between cellular sodium-hydrogen exchange activity and hypertension has been studied in rats and in a small study in humans. Correlation of this transport with weight, fasting insulin and lipid levels, and sodium-lithium countertransport was not available in 1989.

DESIGN NARRATIVE:

The study was cross-sectional. Subjects were stratified by weight: plus or minus 10 percent of desirable weight; 11 to 30 percent over desirable weight; and 30 percent over desirable weight; and by diastolic blood pressure: 80; 80-89; 90-99 mmHg. Blood pressure, height, weight, waist and hip girth, skinfold, fasting and post-glucose load insulin, glucose, lipids, creatinine, maximal rates of red blood cell sodium-lithium countertransport and platelet sodium-hydrogen exchange, pH, and calcium concentrations were measured. The strength and independence among these continuous variables were measured by Pearson correlations, partial correlations, and multiple regressions within each stratum, and if appropriate, over all strata. The study examined the hypotheses that: part of the relationship between obesity and blood pressure was due to insulin effects and/or lipid effects on ion transport; the relationship between ion transport and blood pressure was related to an abnormality of sodium-hydrogen exchange, for which the observed increase in sodium-lithium countertransport was a marker; increased blood pressure was related to the alteration of intracellular pH and/or calcium concentration.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 1991
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

Bunker CH, Wing RR, Becker DJ, Kuller LH. Sodium-lithium countertransport activity is decreased after weight loss in healthy obese men. Metabolism. 1993 Aug;42(8):1052-8. — View Citation

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