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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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