Metabolic SyndromeAIMMYNCT00966407
Assessing Inherited Markers of Metabolic Syndrome in the Young
An observational study of Metabolic Syndrome and Diabetes Mellitus, Type 2, run by Eric Hoffman at 1 site in United States.
Trial summary
The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and colleges/universities nationwide--currently including Howard University (HU), East Carolina University (ECU), and University of Massachusetts, Amherst (U Mass). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Obesity
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2016
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The population from which cohorts will be selected include students, residents, staff, and/or faculty who are present on Howard University, East Carolina University, and/or University of Massachusetts, Amherst campuses and surrounding areas.
Who may be able to join
- between the ages of 18 and 35 years
- post-puberty
- willing and able to provide informed consent
- stable medical and psychosocial status providing a high likelihood of follow-up and compliance with study protocol
- all ethnic backgrounds will be included in this study.
Who cannot join
- evidence of clinically relevant systemic disease associated with disorders of glucose metabolism
- chronic use of glucocorticoid or appetite suppressants
- concomitant use of drugs known to alter glucose metabolism (i.e., metformin, thiazolidinediones, sulfonylurea receptor agonists and inhibitors of alpha-glucoside hydrolase) or other medications known to alter blood levels being tested in this study
- inability to provide the requested fasting blood sample
- pregnancy
- menopause
Show all 16Show fewer
- alcohol dependency (as determined by CAGE screening questionnaire); (8) inability to provide informed consent
- previous diagnosis or treatment for any hematologic-oncologic disorder
- history or current treatment for an eating disorder
- current treatment for weight loss
- history of bariatric surgery
- history of neurosurgical procedure
- participation in another clinical trial involving an investigational drug
- history of psychiatric disorder, which in the opinion of the investigator would affect the conduct of the proposed trial
- age younger than 18 or older than 35 at the time of recruitment
- weight that exceeds the capacity of equipment used for weight measurements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and colleges/universities nationwide--currently including Howard University (HU), East Carolina University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a variety of baseline measures (such as serum biomarkers related to metabolic syndrome, anthropometrics, muscle strength, and fitness testing) along with genetic information from healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype associations that may predispose individuals to developing metabolic syndrome, type 2 diabetes, and/or related diseases such as obesity.
We hypothesized that certain genetic variations will be protective against metabolic syndrome, while others will show a strong correlation with specific components of metabolic syndrome disease. We expect that the study of "pre-symptomatic," young individuals will facilitate the identification of genetic risk loci for metabolic syndrome and type 2 diabetes. Younger populations typically have less confounding variables, and this facilitates normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young subjects can provide more robust longitudinal data, and be recruited into subsequent interventions to reverse the trend towards metabolic syndrome, rather than the more difficult task of reversing type 2 diabetes in older populations. The data collected will be stratified according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how these factors influence disease risk.
- Conditions
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Obesity
- Keywords
- Metabolic Syndrome, Obesity, Genetic risk markers, Single Nucleotide Polymorphisms, Young adults, Fitness testing
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Young Adults | College-age (18-35 years) participants recruited from Howard University, East Carolina University, and University of Massachusetts, Amherst, University of Calgary, Winston-Salem University |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype for specific genes related to obesity, metabolic syndrome, and/or type 2 diabetes; Fasting serum biomarkers; Hand grip strength, muscle strength of upper and lower extremities; Fitness measurements; Body composition measures
Measured: Cross-sectional, one-time measure
Secondary outcomes (1)
Perception of physical fitness; Relationship between physiological measures and genotype variation
Measured: Cross-sectional, one-time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startFeb 2007
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Hoffman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Howard University, University of Massachusetts, Worcester, East Carolina University
- Responsible party
- Sponsor-investigator, Eric Hoffman, Children's National Research Institute
- Investigators
- Eric P Hoffman, Ph.D, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966407
- Sponsor's protocol ID
- CNMC IRB#3842
- Other IDs
- 2P20MD000198-06
- Acronym
- AIMMY
- Status last verified
- Feb 2017
- First submitted
- 24 Aug 2009
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Deschamps CL, Connors KE, Klein MS, Johnsen VL, Shearer J, Vogel HJ, Devaney JM, Gordish-Dressman H, Many GM, Barfield W, Hoffman EP, Kraus WE, Hittel DS. The ACTN3 R577X Polymorphism Is Associated with Cardiometabolic Fitness in Healthy Young Adults. PLoS One. 2015 Jun 24;10(6):e0130644. doi: 10.1371/journal.pone.0130644. eCollection 2015.
PubMed 26107372Many GM, Lutsch A, Connors KE, Shearer J, Brown HC, Ash G, Pescatello LS, Gordish-Dressman H, Barfield W, Dubis G, Houmard JA, Hoffman EP, Hittel DS. Examination of Lifestyle Behaviors and Cardiometabolic Risk Factors in University Students Enrolled in Kinesiology Degree Programs. J Strength Cond Res. 2016 Apr;30(4):1137-46. doi: 10.1519/JSC.0000000000000871.
PubMed 25647655Karlos A, Shearer J, Gnatiuk E, Onyewu C, Many G, Hoffman EP, Hittel DS. Effect of the SORT1 low-density lipoprotein cholesterol locus is sex-specific in a fit, Canadian young-adult population. Appl Physiol Nutr Metab. 2013 Feb;38(2):188-93. doi: 10.1139/apnm-2012-0231. Epub 2012 Nov 1.
PubMed 23438231Arnold TJ, Schweitzer A, Hoffman HJ, Onyewu C, Hurtado ME, Hoffman EP, Klein CJ. Neck and waist circumference biomarkers of cardiovascular risk in a cohort of predominantly African-American college students: a preliminary study. J Acad Nutr Diet. 2014 Jan;114(1):107-16. doi: 10.1016/j.jand.2013.07.005. Epub 2013 Sep 16.
PubMed 24051106
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Inherited Markers of Metabolic Syndrome in the Young
- ClinicalTrials.gov ID
- NCT00966407
- Acronym / sponsor ID
- AIMMY / CNMC IRB#3842
- Conditions
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Obesity
- Keywords
- Metabolic Syndrome, Obesity, Genetic risk markers, Single Nucleotide Polymorphisms, Young adults, Fitness testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Eric HoffmanUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Howard University, University of Massachusetts, Worcester, East Carolina University
- Study start
- Feb 2007 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 26 Aug 2009 (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.
The AIMM Young study is a collaboration between Children's National Medical Center (CNMC) and colleges/universities nationwide--currently including Howard University (HU), East Carolina University (ECU), and University of Massachusetts, Amherst (U Mass). This study obtains a variety of baseline measures (such as serum biomarkers related to metabolic syndrome, anthropometrics, muscle strength, and fitness testing) along with genetic information from healthy college-age (18-35 years) young adults in efforts to identify phenotype-genotype associations that may predispose individuals to developing metabolic syndrome, type 2 diabetes, and/or related diseases such as obesity.
We hypothesized that certain genetic variations will be protective against metabolic syndrome, while others will show a strong correlation with specific components of metabolic syndrome disease. We expect that the study of "pre-symptomatic," young individuals will facilitate the identification of genetic risk loci for metabolic syndrome and type 2 diabetes. Younger populations typically have less confounding variables, and this facilitates normalizing of metabolic syndrome features and environment/lifestyle. Additionally, young subjects can provide more robust longitudinal data, and be recruited into subsequent interventions to reverse the trend towards metabolic syndrome, rather than the more difficult task of reversing type 2 diabetes in older populations. The data collected will be stratified according to gender, age, ethnicity, genotype, and other phenotypic measures to determine how these factors influence disease risk.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Young Adults | – | –College-age (18-35 years) participants recruited from Howard University, East Carolina University, and University of Massachusetts, Amherst, University of Calgary, Winston-Salem University |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The population from which cohorts will be selected include students, residents, staff, and/or faculty who are present on Howard University, East Carolina University, and/or University of Massachusetts, Amherst campuses and surrounding areas.
Key inclusion criteria (5 listed)
- between the ages of 18 and 35 years
- post-puberty
- willing and able to provide informed consent
- stable medical and psychosocial status providing a high likelihood of follow-up and compliance with study protocol
- all ethnic backgrounds will be included in this study.
Key exclusion criteria (16 listed)
- evidence of clinically relevant systemic disease associated with disorders of glucose metabolism
- chronic use of glucocorticoid or appetite suppressants
- concomitant use of drugs known to alter glucose metabolism (i.e., metformin, thiazolidinediones, sulfonylurea receptor agonists and inhibitors of alpha-glucoside hydrolase) or other medications known to alter blood levels being tested in this study
- inability to provide the requested fasting blood sample
- pregnancy
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
Genotype for specific genes related to obesity, metabolic syndrome, and/or type 2 diabetes; Fasting serum biomarkers; Hand grip strength, muscle strength of upper and lower extremities; Fitness measurements; Body composition measures
Time frame: Cross-sectional, one-time measure
1 secondary outcome
Perception of physical fitness; Relationship between physiological measures and genotype variation
Time frame: Cross-sectional, one-time
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 9 Feb 2017.
- Results publication: PubMed 26107372Deschamps CL, Connors KE, Klein MS, Johnsen VL, Shearer J, Vogel HJ, Devaney JM, Gordish-Dressman H, Many GM, Barfield W, Hoffman EP, Kraus WE, Hittel DS. The ACTN3 R577X Polymorphism Is Associated with Cardiometabolic Fitness in Healthy Young Adults. PLoS One. 2015 Jun 24;10(6):e0130644. doi: 10.1371/journal.pone.0130644. eCollection 2015.
- Results publication: PubMed 25647655Many GM, Lutsch A, Connors KE, Shearer J, Brown HC, Ash G, Pescatello LS, Gordish-Dressman H, Barfield W, Dubis G, Houmard JA, Hoffman EP, Hittel DS. Examination of Lifestyle Behaviors and Cardiometabolic Risk Factors in University Students Enrolled in Kinesiology Degree Programs. J Strength Cond Res. 2016 Apr;30(4):1137-46. doi: 10.1519/JSC.0000000000000871.
- Results publication: PubMed 23438231Karlos A, Shearer J, Gnatiuk E, Onyewu C, Many G, Hoffman EP, Hittel DS. Effect of the SORT1 low-density lipoprotein cholesterol locus is sex-specific in a fit, Canadian young-adult population. Appl Physiol Nutr Metab. 2013 Feb;38(2):188-93. doi: 10.1139/apnm-2012-0231. Epub 2012 Nov 1.
- Results publication: PubMed 24051106Arnold TJ, Schweitzer A, Hoffman HJ, Onyewu C, Hurtado ME, Hoffman EP, Klein CJ. Neck and waist circumference biomarkers of cardiovascular risk in a cohort of predominantly African-American college students: a preliminary study. J Acad Nutr Diet. 2014 Jan;114(1):107-16. doi: 10.1016/j.jand.2013.07.005. Epub 2013 Sep 16.
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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.
Eric P Hoffman, Ph.D principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Diabetes Mellitus, Type 2, run by Eric Hoffman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Genotype for specific genes related to obesity, metabolic syndrome, and/or type 2 diabetes; Fasting serum biomarkers; Hand grip strength, muscle strength of upper and lower extremities; Fitness measurements; Body composition measures (time frame: Cross-sectional, one-time measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00966407, which also lists 4 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 9 Feb 2017.