Cardiovascular DiseasesNCT00005164
Insulin Resistance and Blood Pressure Regulation in Blacks
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1983to Aug 1991
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Heart Diseases, Insulin Resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startSep 1983
- Study completionAug 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005164
- Sponsor's protocol ID
- 1036
- Other IDs
- R01HL031802
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
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.
PubMed 6735456Chinese 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
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
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.
PubMed 2427884Canessa 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.
PubMed 2428944Falkner 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.
PubMed 3794120Falkner 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
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
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.
PubMed 3471912Falkner 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
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.
PubMed 3278039Falkner 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
Falkner B. Vascular reactivity and hypertension in childhood. Semin Nephrol. 1989 Sep;9(3):247-52. No abstract available.
PubMed 2675243Santangelo 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.
PubMed 2914085Falkner 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.
PubMed 2630296
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Resistance and Blood Pressure Regulation in Blacks
- ClinicalTrials.gov ID
- NCT00005164
- Acronym / sponsor ID
- 1036
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1983
- Study completion
- Aug 1991 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 6735456Canessa 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.
- BackgroundChinese 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
- BackgroundFalkner 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
- Background: PubMed 2427884Falkner B. Cardiovascular characteristics of the young with borderline hypertension. J Cardiovasc Pharmacol. 1986;8 Suppl 5:S44-7. doi: 10.1097/00005344-198608005-00009.
- Background: PubMed 2428944Canessa 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.
- Background: PubMed 3794120Falkner 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.
- BackgroundFalkner 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
- BackgroundFalkner 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
- Background: PubMed 3471912Falkner 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.
- BackgroundFalkner 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
- Background: PubMed 3278039Falkner B. Sodium sensitivity: a determinant of essential hypertension. J Am Coll Nutr. 1988 Feb;7(1):35-41. doi: 10.1080/07315724.1988.10720218.
- BackgroundFalkner 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Hypertension, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005164, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.