Cardiovascular DiseasesNCT00005709
Lipoprotein Metabolism in Hypertensive African-Americans
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To study relationships among lipoprotein metabolism, hypertension, and hyperinsulinemia-insulin resistance in African American males and females. The study was part of a Collaborative Project on Minority Health which investigated the mechanisms by which insulin contributes to cardiovascular disease. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hyperinsulinism
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1993to Aug 1998
- 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 study relationships among lipoprotein metabolism, hypertension, and hyperinsulinemia-insulin resistance in African American males and females. The study was part of a Collaborative Project on Minority Health which investigated the mechanisms by which insulin contributes to cardiovascular disease.
Read the detailed description
BACKGROUND:
The study was part of the initiative "Collaborative Projects (R01s) on Minority Health". The concept for the initiative was developed by the NHLBI staff after the 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The initiative was approved at the September 1992 National Heart, Lung, and Blood Advisory Council and released in October 1992.
Julian Marsh was one of three investigators in a collaborative program with Bonita Falkner as Program Coordinator.
DESIGN NARRATIVE:
In a sub-set of subjects with either high or low plasma insulin levels after a glucose challenge (insulin sensitive or insulin resistant), the investigators determined the fractional and absolute synthesis and catabolic rates of apolipoproteins B and A-I, the dominant lipoproteins of Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL). They used stable isotopes and multicompartmental kinetic analysis following an oral bolus dose of deuteroleucine. They hypothesized that in hypertensive African Americans with hyperinsulinemia, more of the smaller Very Low Density (VLDL) particles are secreted and converted to LDL.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hyperinsulinism, Hypertension, Insulin Resistance
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hyperinsulinism, Hypertension, 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 1993
- Study completionAug 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- NCT00005709
- Sponsor's protocol ID
- 4918
- Other IDs
- R01HL051536
- Status last verified
- Jun 2001
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Sumner AE, Kushner H, Tulenko TN, Falkner B, Marsh JB. The relationship in African-Americans of sex differences in insulin-mediated suppression of nonesterified fatty acids to sex differences in fasting triglyceride levels. Metabolism. 1997 Apr;46(4):400-5. doi: 10.1016/s0026-0495(97)90055-x.
PubMed 9109843Sumner AE, Kushner H, Lakota CA, Falkner B, Marsh JB. Gender differences in insulin-induced free fatty acid suppression: studies in an African American population. Lipids. 1996 Mar;31 Suppl:S275-8. doi: 10.1007/BF02637090.
PubMed 8729133Sumner AE, Falkner B, Diffenderfer MR, Barrett PH, Marsh JB. A study of the metabolism of apolipoprotein B100 in relation to insulin resistance in African American males. Proc Soc Exp Biol Med. 1999 Sep;221(4):352-60. doi: 10.1046/j.1525-1373.1999.d01-92.x.
PubMed 10460697
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
- Lipoprotein Metabolism in Hypertensive African-Americans
- ClinicalTrials.gov ID
- NCT00005709
- Acronym / sponsor ID
- 4918
- Conditions
- Cardiovascular Diseases, Heart Diseases, Hyperinsulinism, Hypertension, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1993
- Study completion
- Aug 1998 (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 study relationships among lipoprotein metabolism, hypertension, and hyperinsulinemia-insulin resistance in African American males and females. The study was part of a Collaborative Project on Minority Health which investigated the mechanisms by which insulin contributes to cardiovascular disease.
Detailed description
BACKGROUND:
The study was part of the initiative "Collaborative Projects (R01s) on Minority Health". The concept for the initiative was developed by the NHLBI staff after the 1993 Report of the Committee on Appropriations, House of Representatives, encouraged the NHLBI to establish minority centers to facilitate the diagnosis and treatment of cardiovascular diseases. The initiative was approved at the September 1992 National Heart, Lung, and Blood Advisory Council and released in October 1992.
Julian Marsh was one of three investigators in a collaborative program with Bonita Falkner as Program Coordinator.
DESIGN NARRATIVE:
In a sub-set of subjects with either high or low plasma insulin levels after a glucose challenge (insulin sensitive or insulin resistant), the investigators determined the fractional and absolute synthesis and catabolic rates of apolipoproteins B and A-I, the dominant lipoproteins of Low Density Lipoprotein (LDL) and High Density Lipoprotein (HDL). They used stable isotopes and multicompartmental kinetic analysis following an oral bolus dose of deuteroleucine. They hypothesized that in hypertensive African Americans with hyperinsulinemia, more of the smaller Very Low Density (VLDL) particles are secreted and converted to LDL.
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 9109843Sumner AE, Kushner H, Tulenko TN, Falkner B, Marsh JB. The relationship in African-Americans of sex differences in insulin-mediated suppression of nonesterified fatty acids to sex differences in fasting triglyceride levels. Metabolism. 1997 Apr;46(4):400-5. doi: 10.1016/s0026-0495(97)90055-x.
- Background: PubMed 8729133Sumner AE, Kushner H, Lakota CA, Falkner B, Marsh JB. Gender differences in insulin-induced free fatty acid suppression: studies in an African American population. Lipids. 1996 Mar;31 Suppl:S275-8. doi: 10.1007/BF02637090.
- Background: PubMed 10460697Sumner AE, Falkner B, Diffenderfer MR, Barrett PH, Marsh JB. A study of the metabolism of apolipoprotein B100 in relation to insulin resistance in African American males. Proc Soc Exp Biol Med. 1999 Sep;221(4):352-60. doi: 10.1046/j.1525-1373.1999.d01-92.x.
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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 Heart Diseases, 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 NCT00005709, which also lists 3 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.