Completed
HERITAGEHeritage Study--Genetics, Exercise and Risk Factors
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What is being tested
exercise program
Other
Who is being recruted
Cardiovascular Diseases
+1
+ Heart Diseases+ Diabetes Mellitus, Non-insulin DependentSee all eligibility criteria
How is the trial designed
Basic Science Study
Interventional
Study Start: July 1992
See protocol details
Summary
Principal SponsorWashington University School of Medicine
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 1992Actual date on which the first participant was enrolled.
To document the role of the genotype in the cardiovascular and metabolic responses to aerobic exercise-training and the contribution of inherited factors in the changes brought about by regular exercise for several cardiovascular disease and diabetes risk factors. A consortium of laboratories from five institutions in the United States and Canada are carrying out this study.
BACKGROUND:
This research should increase our understanding of human variation, the genetics of adaptation to exercise-training and of the concomitant changes in cardiovascular disease and diabetes risk factors.
DESIGN NARRATIVE:
A total of 742 sedentary subjects were recruited, initially tested, exercise-trained in the laboratory with the same program for 20 weeks, and re-tested. The subjects came from families of Caucasian descent with both parents and three biological adult offspring and families of African-American ancestry. Oxygen uptake, expiratory volume and respiratory exchange ratio, blood pressure, heart rate, blood lactate, glucose, glycerol and free-fatty acids, stroke volume and cardiac output were measured during exercise before and after training and maximal oxygen uptake was determined. Plasma lipids, lipoproteins and apoproteins, glucose tolerance and insulin response to an intravenous glucose load, plasma sex steroids and glucocorticoids, resting systolic and diastolic blood pressures, and body fat and regional fat distribution were also assessed. Dietary habits, level of habitual physical activity and other lifestyle components were assessed by questionnaires. Genetic analyses included the determination of the heritability level for each phenotype and its response to regular exercise, testing for the presence of paternal or maternal effects, sex-limited effects, major gene effects and segregation patterns. Multivariate genetic analyses and complex segregation analyses were used to develop hypotheses concerning the genetic basis of the response to exercise-training.
The study was renewed in September 1997 to perform analyses of the data collected under Phase I. A series of nongenetic studies were undertaken on the dataset. Physiological, behavioral, and social determinants of maximal and submaximal indicators of cardiorespiratory endurance in the sedentary state and in the response to training were investigated taking into account the contributions of age, gender, and race. Similar analyses were conducted on the cardiovascular disease and non-insulin dependent diabetes mellitus (NIDDM) risk factors monitored in the study. Genetic analyses determined the heritability levels and tested for paternal or maternal effects, major gene effects, and segregation patterns which were used to develop hypotheses concerning genetic bases of the response to endurance exercise. A panel of candidate genes were typed and used for association and linkage studies. Differential display analysis of skeletal muscle transcripts were used to identify new candidate genes for the response to endurance exercise. Finally, a genome wide search was undertaken to isolate candidate genomic regions and positional candidate genes for the response of cardiorespiratory endurance and cardiovascular and NIDDM risk factor phenotypes.
The study was renewed in 2001 for four years to continue analyses of the data.
Principal SponsorWashington University School of Medicine
Last updated: May 29, 2014
Sourced from a government-validated database.Claim as a partner
ProtocolThis section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
EligibilityResearchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Diabetes Mellitus, Non-insulin Dependent
Diabetes Mellitus
Criteria
Ensure optimum compatibilityAdd your profile to know your probability eligibility score.
CompletedNo study centers