Cardiovascular DiseasesNCT00005239
Genetic Epidemiology of Coronary Heart Disease Risk in Women Twins
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine genetic and environmental influences on several recently identified coronary heart disease risk factors in identical and fraternal adult women twins. The risk factors included low density lipoprotein (LDL) subclass patterns, plasma apolipoprotein levels, body fat distribution, and serum insulin levels. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1989to Dec 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 examine genetic and environmental influences on several recently identified coronary heart disease risk factors in identical and fraternal adult women twins. The risk factors included low density lipoprotein (LDL) subclass patterns, plasma apolipoprotein levels, body fat distribution, and serum insulin levels.
Read the detailed description
BACKGROUND:
In 1974, a twin registry was established from members of the Kaiser Permanente Medical Care Program's Northern California region. In all, 9,821 twin pairs were enrolled. In 1978-1979, 434 pairs of female twins were recruited from the registry for a clinical examination of coronary heart disease risk factors. The clinical examination included an extensive health questionnaire, measurements of plasma lipids and serum chemistries, analyses of genetic markers for determination of zygosity, measurement of expired air carbon monoxide and serum thiocyanate levels, and a complete physical examination. During the ten years since the first examination, several new or more specific coronary heart disease risk factors have been recognized, including low density lipoprotein and insulin levels, and the anatomic distribution of body fat.
DESIGN NARRATIVE:
All women who participated in the first examination were invited to participate in the second examination. Medical records and/or death certificates were obtained to document coronary heart disease events. Questionnaires were used to collect information on health history, nutrition, and physical activity. A clinical examination assessed blood pressure, a variety of anthropometric measures and cardiovascular fitness. Blood specimens were collected for clinical chemistry and lipid/lipoprotein profiles. To assess genetic influence, the heritability of each of the risk factors was estimated. Blood was frozen for future studies of polymorphic DNA markers. Using the monozygotic co-twin control method, the effects of environmental or behavioral factors on these risk factors were assessed after controlling for genetic factors that could explain their association. Two hypotheses were examined that could be uniquely addressed using twin data. First, the association of body fat distribution with other coronary heart disease risk factors was mediated by serum insulin levels. Secondly, cardiovascular fitness explained in part the association of physical activity with coronary heart disease risk factors such as HDL-cholesterol and insulin levels. Lipoprotein analyses were conducted at Donner Laboratory at Berkeley.
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, Coronary Disease, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
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 startJan 1989
- Study completionDec 1991
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Investigators
- Joseph Selby, Kaiser Foundation Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005239
- Sponsor's protocol ID
- 1120
- Other IDs
- R01HL041830
- Status last verified
- Jun 2004
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Austin MA, Sandholzer C, Selby JV, Newman B, Krauss RM, Utermann G. Lipoprotein(a) in women twins: heritability and relationship to apolipoprotein(a) phenotypes. Am J Hum Genet. 1992 Oct;51(4):829-40.
PubMed 1415225Edwards KL, Austin MA, Jarvik GP. Evidence for genetic influences on smoking in adult women twins. Clin Genet. 1995 May;47(5):236-44. doi: 10.1111/j.1399-0004.1995.tb04303.x.
PubMed 7554348Mayer EJ, Newman B, Quesenberry CP Jr, Selby JV. Usual dietary fat intake and insulin concentrations in healthy women twins. Diabetes Care. 1993 Nov;16(11):1459-69. doi: 10.2337/diacare.16.11.1459.
PubMed 8299435Austin MA, Hokanson JE. Epidemiology of triglycerides, small dense low-density lipoprotein, and lipoprotein(a) as risk factors for coronary heart disease. Med Clin North Am. 1994 Jan;78(1):99-115. doi: 10.1016/s0025-7125(16)30178-x.
PubMed 8283937Mayer EJ, Newman B, Quesenberry CP Jr, Friedman GD, Selby JV. Alcohol consumption and insulin concentrations. Role of insulin in associations of alcohol intake with high-density lipoprotein cholesterol and triglycerides. Circulation. 1993 Nov;88(5 Pt 1):2190-7. doi: 10.1161/01.cir.88.5.2190.
PubMed 8222114Selby JV, Austin MA, Newman B, Zhang D, Quesenberry CP Jr, Mayer EJ, Krauss RM. LDL subclass phenotypes and the insulin resistance syndrome in women. Circulation. 1993 Aug;88(2):381-7. doi: 10.1161/01.cir.88.2.381.
PubMed 8339401Austin MA, Newman B, Selby JV, Edwards K, Mayer EJ, Krauss RM. Genetics of LDL subclass phenotypes in women twins. Concordance, heritability, and commingling analysis. Arterioscler Thromb. 1993 May;13(5):687-95. doi: 10.1161/01.atv.13.5.687.
PubMed 8485120Edwards KL, Austin MA, Newman B, Mayer E, Krauss RM, Selby JV. Multivariate analysis of the insulin resistance syndrome in women. Arterioscler Thromb. 1994 Dec;14(12):1940-5. doi: 10.1161/01.atv.14.12.1940.
PubMed 7981183Selby JV, Austin MA, Sandholzer C, Quesenberry CP Jr, Zhang D, Mayer E, Utermann G. Environmental and behavioral influences on plasma lipoprotein(a) concentration in women twins. Prev Med. 1994 May;23(3):345-53. doi: 10.1006/pmed.1994.1048.
PubMed 8078856
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Epidemiology of Coronary Heart Disease Risk in Women Twins
- ClinicalTrials.gov ID
- NCT00005239
- Acronym / sponsor ID
- 1120
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1989
- Study completion
- Dec 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 examine genetic and environmental influences on several recently identified coronary heart disease risk factors in identical and fraternal adult women twins. The risk factors included low density lipoprotein (LDL) subclass patterns, plasma apolipoprotein levels, body fat distribution, and serum insulin levels.
Detailed description
BACKGROUND:
In 1974, a twin registry was established from members of the Kaiser Permanente Medical Care Program's Northern California region. In all, 9,821 twin pairs were enrolled. In 1978-1979, 434 pairs of female twins were recruited from the registry for a clinical examination of coronary heart disease risk factors. The clinical examination included an extensive health questionnaire, measurements of plasma lipids and serum chemistries, analyses of genetic markers for determination of zygosity, measurement of expired air carbon monoxide and serum thiocyanate levels, and a complete physical examination. During the ten years since the first examination, several new or more specific coronary heart disease risk factors have been recognized, including low density lipoprotein and insulin levels, and the anatomic distribution of body fat.
DESIGN NARRATIVE:
All women who participated in the first examination were invited to participate in the second examination. Medical records and/or death certificates were obtained to document coronary heart disease events. Questionnaires were used to collect information on health history, nutrition, and physical activity. A clinical examination assessed blood pressure, a variety of anthropometric measures and cardiovascular fitness. Blood specimens were collected for clinical chemistry and lipid/lipoprotein profiles. To assess genetic influence, the heritability of each of the risk factors was estimated. Blood was frozen for future studies of polymorphic DNA markers. Using the monozygotic co-twin control method, the effects of environmental or behavioral factors on these risk factors were assessed after controlling for genetic factors that could explain their association. Two hypotheses were examined that could be uniquely addressed using twin data. First, the association of body fat distribution with other coronary heart disease risk factors was mediated by serum insulin levels. Secondly, cardiovascular fitness explained in part the association of physical activity with coronary heart disease risk factors such as HDL-cholesterol and insulin levels. Lipoprotein analyses were conducted at Donner Laboratory at Berkeley.
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 18 Feb 2016.
- Background: PubMed 1415225Austin MA, Sandholzer C, Selby JV, Newman B, Krauss RM, Utermann G. Lipoprotein(a) in women twins: heritability and relationship to apolipoprotein(a) phenotypes. Am J Hum Genet. 1992 Oct;51(4):829-40.
- Background: PubMed 7554348Edwards KL, Austin MA, Jarvik GP. Evidence for genetic influences on smoking in adult women twins. Clin Genet. 1995 May;47(5):236-44. doi: 10.1111/j.1399-0004.1995.tb04303.x.
- Background: PubMed 8299435Mayer EJ, Newman B, Quesenberry CP Jr, Selby JV. Usual dietary fat intake and insulin concentrations in healthy women twins. Diabetes Care. 1993 Nov;16(11):1459-69. doi: 10.2337/diacare.16.11.1459.
- Background: PubMed 8283937Austin MA, Hokanson JE. Epidemiology of triglycerides, small dense low-density lipoprotein, and lipoprotein(a) as risk factors for coronary heart disease. Med Clin North Am. 1994 Jan;78(1):99-115. doi: 10.1016/s0025-7125(16)30178-x.
- Background: PubMed 8222114Mayer EJ, Newman B, Quesenberry CP Jr, Friedman GD, Selby JV. Alcohol consumption and insulin concentrations. Role of insulin in associations of alcohol intake with high-density lipoprotein cholesterol and triglycerides. Circulation. 1993 Nov;88(5 Pt 1):2190-7. doi: 10.1161/01.cir.88.5.2190.
- Background: PubMed 8339401Selby JV, Austin MA, Newman B, Zhang D, Quesenberry CP Jr, Mayer EJ, Krauss RM. LDL subclass phenotypes and the insulin resistance syndrome in women. Circulation. 1993 Aug;88(2):381-7. doi: 10.1161/01.cir.88.2.381.
- Background: PubMed 8485120Austin MA, Newman B, Selby JV, Edwards K, Mayer EJ, Krauss RM. Genetics of LDL subclass phenotypes in women twins. Concordance, heritability, and commingling analysis. Arterioscler Thromb. 1993 May;13(5):687-95. doi: 10.1161/01.atv.13.5.687.
- Background: PubMed 7981183Edwards KL, Austin MA, Newman B, Mayer E, Krauss RM, Selby JV. Multivariate analysis of the insulin resistance syndrome in women. Arterioscler Thromb. 1994 Dec;14(12):1940-5. doi: 10.1161/01.atv.14.12.1940.
- Background: PubMed 8078856Selby JV, Austin MA, Sandholzer C, Quesenberry CP Jr, Zhang D, Mayer E, Utermann G. Environmental and behavioral influences on plasma lipoprotein(a) concentration in women twins. Prev Med. 1994 May;23(3):345-53. doi: 10.1006/pmed.1994.1048.
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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.
Joseph Selby
Kaiser Foundation Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, 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 18 Feb 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 NCT00005239, which also lists 9 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 18 Feb 2016.