Insulin Resistance and Blood Pressure Regulation in Blacks
Primary Purpose
Cardiovascular Diseases, Hypertension, Heart Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005164
First Posted
May 25, 2000
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005164
Brief Title
Insulin Resistance and Blood Pressure Regulation in Blacks
Study Type
Observational
2. Study Status
Record Verification Date
June 2000
Overall Recruitment Status
Completed
Study Start Date
September 1983 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 1991 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine the role of insulin resistance in peripheral vascular dynamics, sodium sensitivity, and blood pressure regulation in a young representative Black population and in a group of young Blacks at high risk for hypertension.
Detailed Description
BACKGROUND:
Epidemiologic studies have demonstrated a greater prevalence of essential hypertension in Blacks with a disproportionately greater hypertension related mortality in Blacks. Similar vascular consequences occur with diabetes and obesity. These three diseases not only share a common outcome, but also overlap in occurrence with Blacks having greater prevalence rates in the three disorders. Insulin resistance has been documented in all three disorders and may contribute significantly to the vascular disease.
This project originated in response to a Request for Applications on Biobehavioral Factors Affecting Hypertension in Blacks issued in December 1982. The original project was supported by the RFA for three years. The first three years of the study focussed on the hypothesis that sodium loading would augment cardiovascular responses of psychogenic stress in Blacks at high risk for hypertension. The first phase of the study examined and compared 80 Blacks and whites, 18-22 years of age. The second phase involved an additional 40 Black borderline hypertensives who were exposed to the same set of studies designed to examine possible interactions between neurogenic and renal controlled volume mechanisms in essential hypertension.
The project was renewed as a regular research grant in 1986 and was designed to investigated biobehavioral factors in blood pressure control. In 1988, the study on insulin resistance was funded and continued through 1990.
DESIGN NARRATIVE:
Subjects in this project consisted of Blacks who were enrolled in the Collaborative Perinatal Project (CPP) at birth and who had been studied longitudinally in adolescence and young adulthood. Each subject brought to the study data on blood pressure, growth, and maturation from birth through late adolescence.
Peripheral vascular structure was studied using measures of forearm blood flow and forearm vascular resistance. Measurements of peripheral vascular structure were compared to data on sodium sensitivity and potassium sensitivity in the population. Insulin resistance was studied using the euglycemic hyperinsulinemic clamp technique. Variations in the activity of the sodium-potassium pump and sodium-hydrogen exchange in red cells were correlated with insulin resistance to determine if hyperinsulinemia alters cation transport rates.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Hypertension, Heart Diseases, Insulin Resistance
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
6735456
Citation
Canessa M, Spalvins A, Adragna N, Falkner B. Red cell sodium countertransport and cotransport in normotensive and hypertensive blacks. Hypertension. 1984 May-Jun;6(3):344-51. doi: 10.1161/01.hyp.6.3.344.
Results Reference
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Citation
Chinese M, Solomon H, Falkner B, Adragna N, Ellison RC: Familial Aggregation of Sodium Countertransport and Cotransport and Essential Hypertension in: Topics on Pathophysiology of Hypertension. Villareal H, Sambhi MP, Nijhoff Publish. Boston, p. 78-87, 1984
Results Reference
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Citation
Falkner B, Katz S, Chinese M, Kushner H: The Response to Chronic Oral Sodium Loading in Young Blacks. Hypertension, 8 (Suppl I): I-165-168, 1986
Results Reference
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PubMed Identifier
2427884
Citation
Falkner B. Cardiovascular characteristics of the young with borderline hypertension. J Cardiovasc Pharmacol. 1986;8 Suppl 5:S44-7. doi: 10.1097/00005344-198608005-00009.
Results Reference
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PubMed Identifier
2428944
Citation
Canessa M, Bize I, Spalvins A, Falkner B, Katz S. Na-K-C1 cotransport and Na pump in red cells of young blacks and blood pressure response to salt loading. J Clin Hypertens. 1986 Jun;2(2):101-8.
Results Reference
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PubMed Identifier
3794120
Citation
Falkner B, Ragonesi S. Psychosocial stress and reactivity as risk factors of cardiovascular disease. J Am Acad Child Psychiatry. 1986 Nov;25(6):779-84. doi: 10.1016/s0002-7138(09)60195-3. No abstract available.
Results Reference
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Citation
Falkner B, Light K: The Interactive Effects of Stress and Dietary Sodium on Cardiovascular Reactivity. In: J Hypertens, Stress, Reactivity, and Cardiovascular Disease: Status and Prospects. Eds. Matthews L, Weiss SM, Detre T, Dembroski T, Falkner B, Manuch S, Williams R (Eds), John Wiley and Sons, Inc. New York, p 329-341, 1986
Results Reference
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Citation
Falkner B: Mild Hypertension in Adolescence. In: Mild Hypertension: From Drug Trials to Practice. Strasser T, Gaten D, (Eds) Raven Press, New York, p 279-283, 1987
Results Reference
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PubMed Identifier
3471912
Citation
Falkner B, Kushner H, Khalsa DK, Canessa M, Katz S. Sodium sensitivity, growth and family history of hypertension in young blacks. J Hypertens Suppl. 1986 Dec;4(5):S381-3.
Results Reference
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Citation
Falkner B: Reactivity to Mental Stress in Hypertension and Prehypertension in: Handbook of Hypertension, Vol. 10. Behavioral Factors in Hypertension, Editor Julius S. and Bassett DR. Elsevier Science Publishers. B.V., 1987
Results Reference
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PubMed Identifier
3278039
Citation
Falkner B. Sodium sensitivity: a determinant of essential hypertension. J Am Coll Nutr. 1988 Feb;7(1):35-41. doi: 10.1080/07315724.1988.10720218.
Results Reference
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Citation
Falkner B: Measurement of Volume Regulation: Renal Function. in: Schneiderman N, Kaufman P and Weiss SM (Eds). Handbook of Research Methods in Cardiovascular Behavioral Medicine. New York: Plenum Publishing Corporation, 1989
Results Reference
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PubMed Identifier
2675243
Citation
Falkner B. Vascular reactivity and hypertension in childhood. Semin Nephrol. 1989 Sep;9(3):247-52. No abstract available.
Results Reference
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PubMed Identifier
2914085
Citation
Santangelo K, Falkner B, Kushner H. Forearm hemodynamics at rest and stress in borderline hypertensive adolescents. Am J Hypertens. 1989 Jan;2(1):52-6. doi: 10.1093/ajh/2.1.52.
Results Reference
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PubMed Identifier
2630296
Citation
Falkner B, Kushner H. Race differences in stress-induced reactivity in young adults. Health Psychol. 1989;8(5):613-27. doi: 10.1037//0278-6133.8.5.613.
Results Reference
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PubMed Identifier
2295513
Citation
Falkner B, Kushner H. Effect of chronic sodium loading on cardiovascular response in young blacks and whites. Hypertension. 1990 Jan;15(1):36-43. doi: 10.1161/01.hyp.15.1.36.
Results Reference
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PubMed Identifier
2190920
Citation
Falkner B. Differences in blacks and whites with essential hypertension: biochemistry and endocrine. State of the art lecture. Hypertension. 1990 Jun;15(6 Pt 2):681-6. doi: 10.1161/01.hyp.15.6.681.
Results Reference
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PubMed Identifier
2246037
Citation
Falkner B, Hulman S, Tannenbaum J, Kushner H. Insulin resistance and blood pressure in young black men. Hypertension. 1990 Dec;16(6):706-11. doi: 10.1161/01.hyp.16.6.706.
Results Reference
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PubMed Identifier
2228151
Citation
Canessa M, Laski C, Falkner B. Red blood cell Na+ transport as a predictor of blood pressure response to Na+ load in young blacks and whites. Hypertension. 1990 Nov;16(5):508-14. doi: 10.1161/01.hyp.16.5.508.
Results Reference
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Citation
Falkner B: Etiologic Factors in Essential Hypertension. Loggie J, Robson A (Eds), in: Pediatric and Adolescent Hypertension, 1992.
Results Reference
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Citation
Falkner B, Rabinowitz AI, Michel SH: Nutrition and Blood Pressure in Childhood: In: Nutritional Factors in Hypertension, Langford H, Levine B (Eds), Alan R Liss, Inc., New York, 1990.
Results Reference
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PubMed Identifier
1986997
Citation
Falkner B, Kushner H. Interaction of sodium sensitivity and stress in young adults. Hypertension. 1991 Jan;17(1 Suppl):I162-5. doi: 10.1161/01.hyp.17.1_suppl.i162.
Results Reference
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Insulin Resistance and Blood Pressure Regulation in Blacks
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