Cardiovascular DiseasesNCT00005342
Weight Set-Point and HDL Concentration in Runners
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To investigate the differences in diet, fat cell morphology and lipoprotein metabolism in previously- overweight and naturally lean men and women who ran and who lived sedentary lifestyles in order to better understand the relationship between lipoprotein metabolism and weight set-point. 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, Obesity
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1993to Apr 1997
- 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 investigate the differences in diet, fat cell morphology and lipoprotein metabolism in previously- overweight and naturally lean men and women who ran and who lived sedentary lifestyles in order to better understand the relationship between lipoprotein metabolism and weight set-point.
Read the detailed description
BACKGROUND:
The elevated high-density lipoprotein (HDL) cholesterol concentrations of long distance runners has been ascribed almost exclusively to increased muscle lipoprotein lipase. Based on data collected in cross-sectional and longitudinal studies, the investigators proposed an alternative theory: long-distance runners had the HDL-cholesterol metabolism of men who were below their sedentary weight rather than the HDL-cholesterol metabolism of lean sedentary men who were at their usual sedentary weight. In other analyses, they found that the most significant determinant of male runners' plasma HDL-cholesterol concentrations was the difference between the runners' greatest weight and their current weight. HDL- cholesterol levels were highest in runners who had lost the most weight, i.e., highest in those who were presumed to be the furthest below their weight set-point
The study was a result of a Program Announcement (PA) released in October, 1994 on Physical Activity and Cardiopulmonary Health. The PA was jointly sponsored by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research.
DESIGN NARRATIVE:
In this cross-sectional study, runners and sedentary men and women were measured for lipoprotein cholesterol, triglycerides, polyacrylamide gel electrophoresis of HDL and low-density lipoprotein subclasses, apolipoproteins A-I and B, intravenous fat clearance rate, post-heparin lipoprotein lipase and hepatic lipase, adipose tissue lipoprotein lipase, cholesteryl ester transfer activity, diet, percent body fat, and regional adiposity. It was hoped that the survey would confirm or reject the weight set-point hypothesis, provide a possible explanation of the lipoprotein differences between male and female runners, and elucidate the mechanism for the lipoprotein changes that occur during exercise-induced weight loss.
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, Obesity
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Obesity
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 startMay 1993
- Study completionApr 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- NCT00005342
- Sponsor's protocol ID
- 4205
- Other IDs
- R01HL045652
- Status last verified
- Jul 2000
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Williams PT, Krauss RM. Associations of age, adiposity, menopause, and alcohol intake with low-density lipoprotein subclasses. Arterioscler Thromb Vasc Biol. 1997 Jun;17(6):1082-90. doi: 10.1161/01.atv.17.6.1082.
PubMed 9194758Williams PT. Deviations from maximum weight predict high-density lipoprotein cholesterol levels in runners: the National Runners' Health Study. Int J Obes Relat Metab Disord. 1997 Jan;21(1):6-13. doi: 10.1038/sj.ijo.0800352.
PubMed 9023594Williams PT. Evidence for the incompatibility of age-neutral overweight and age-neutral physical activity standards from runners. Am J Clin Nutr. 1997 May;65(5):1391-6. doi: 10.1093/ajcn/65.5.1391.
PubMed 9129467Williams PT, Dreon DM, Blanche PJ, Krauss RM. Variability of plasma HDL subclass concentrations in men and women over time. Arterioscler Thromb Vasc Biol. 1997 Apr;17(4):702-6. doi: 10.1161/01.atv.17.4.702.
PubMed 9108783Williams PT. Relationship of distance run per week to coronary heart disease risk factors in 8283 male runners. The National Runners' Health Study. Arch Intern Med. 1997 Jan 27;157(2):191-8.
PubMed 9009976Williams PT. High-density lipoprotein cholesterol and other risk factors for coronary heart disease in female runners. N Engl J Med. 1996 May 16;334(20):1298-303. doi: 10.1056/NEJM199605163342004.
PubMed 8609947
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Set-Point and HDL Concentration in Runners
- ClinicalTrials.gov ID
- NCT00005342
- Acronym / sponsor ID
- 4205
- Conditions
- Cardiovascular Diseases, Heart Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1993
- Study completion
- Apr 1997 (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 investigate the differences in diet, fat cell morphology and lipoprotein metabolism in previously- overweight and naturally lean men and women who ran and who lived sedentary lifestyles in order to better understand the relationship between lipoprotein metabolism and weight set-point.
Detailed description
BACKGROUND:
The elevated high-density lipoprotein (HDL) cholesterol concentrations of long distance runners has been ascribed almost exclusively to increased muscle lipoprotein lipase. Based on data collected in cross-sectional and longitudinal studies, the investigators proposed an alternative theory: long-distance runners had the HDL-cholesterol metabolism of men who were below their sedentary weight rather than the HDL-cholesterol metabolism of lean sedentary men who were at their usual sedentary weight. In other analyses, they found that the most significant determinant of male runners' plasma HDL-cholesterol concentrations was the difference between the runners' greatest weight and their current weight. HDL- cholesterol levels were highest in runners who had lost the most weight, i.e., highest in those who were presumed to be the furthest below their weight set-point
The study was a result of a Program Announcement (PA) released in October, 1994 on Physical Activity and Cardiopulmonary Health. The PA was jointly sponsored by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research.
DESIGN NARRATIVE:
In this cross-sectional study, runners and sedentary men and women were measured for lipoprotein cholesterol, triglycerides, polyacrylamide gel electrophoresis of HDL and low-density lipoprotein subclasses, apolipoproteins A-I and B, intravenous fat clearance rate, post-heparin lipoprotein lipase and hepatic lipase, adipose tissue lipoprotein lipase, cholesteryl ester transfer activity, diet, percent body fat, and regional adiposity. It was hoped that the survey would confirm or reject the weight set-point hypothesis, provide a possible explanation of the lipoprotein differences between male and female runners, and elucidate the mechanism for the lipoprotein changes that occur during exercise-induced weight loss.
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 29 Feb 2016.
- Background: PubMed 9194758Williams PT, Krauss RM. Associations of age, adiposity, menopause, and alcohol intake with low-density lipoprotein subclasses. Arterioscler Thromb Vasc Biol. 1997 Jun;17(6):1082-90. doi: 10.1161/01.atv.17.6.1082.
- Background: PubMed 9023594Williams PT. Deviations from maximum weight predict high-density lipoprotein cholesterol levels in runners: the National Runners' Health Study. Int J Obes Relat Metab Disord. 1997 Jan;21(1):6-13. doi: 10.1038/sj.ijo.0800352.
- Background: PubMed 9129467Williams PT. Evidence for the incompatibility of age-neutral overweight and age-neutral physical activity standards from runners. Am J Clin Nutr. 1997 May;65(5):1391-6. doi: 10.1093/ajcn/65.5.1391.
- Background: PubMed 9108783Williams PT, Dreon DM, Blanche PJ, Krauss RM. Variability of plasma HDL subclass concentrations in men and women over time. Arterioscler Thromb Vasc Biol. 1997 Apr;17(4):702-6. doi: 10.1161/01.atv.17.4.702.
- Background: PubMed 9009976Williams PT. Relationship of distance run per week to coronary heart disease risk factors in 8283 male runners. The National Runners' Health Study. Arch Intern Med. 1997 Jan 27;157(2):191-8.
- Background: PubMed 8609947Williams PT. High-density lipoprotein cholesterol and other risk factors for coronary heart disease in female runners. N Engl J Med. 1996 May 16;334(20):1298-303. doi: 10.1056/NEJM199605163342004.
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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 29 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 NCT00005342, which also lists 6 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 29 Feb 2016.