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RESILIENCE: Personalizing Cardiovascular Health (RESILIENCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04551872
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
Obesity is a rapidly growing epidemic that is associated with the development of cardiovascular disease (CVD). However, some individuals with obesity appear to be resistant to CVD, and other individuals demonstrate resilience to obesity and CVD risk factors. The investigator's overall objective is to understand factors contributing to the heterogeneity of CVD resistance and resilience among individuals with obesity at Duke.

Condition or disease Intervention/treatment Phase
Obesity Cardiovascular Risk Factor Behavioral: Digital weight loss intervention Not Applicable

Detailed Description:
The investigator aims to recruit participants with 4 phenotypes: 200 participants with obesity (BMI ≥ 30) and high 10-year ASCVD risk (≥20%), 200 participants with obesity (BMI ≥ 30) and low 10-year ASCVD risk (<7.5%), 100 participants with normal weight (BMI 18-25) and high 10-year ASCVD risk (≥20%), and 100 participants with normal weight (BMI 18-25) and low 10-year ASCVD risk (<7.5%). Clinical, behavioral, and molecular characteristics will be compared at baseline between the 4 groups to understand heterogeneity between obesity and risk for CVD, and participants with obesity will undergo a 6-month weight loss intervention. In individuals with obesity, clinical, behavioral, and molecular characteristics will be compared between baseline and 6 months to understand (a) predictors of response to the intervention and (b) how these factors change with weight loss. Differences in branched-chain amino acids will be compared between all groups, both at baseline and at 6 months (for those participants undergoing the digital-weight loss intervention). Other clinical, behavioral, metabolomic, genetic, and microbiome parameters will also be compared in an exploratory fashion. There may be possible risk of loss of confidentiality, but this risk is low and measures will be taken to minimize this risk.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Personalizing Cardiovascular Health: A Population Approach to Promoting CVD Resistance and Resilience Among Individuals With Obesity
Actual Study Start Date : September 22, 2020
Estimated Primary Completion Date : September 22, 2022
Estimated Study Completion Date : September 22, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: Obese High Risk
200 participants with BMI ≥30 and 10-year ASCVD risk ≥20%
Behavioral: Digital weight loss intervention
Participants with obesity enter into a proven 6 month weight loss program that utilizes health coaching and goal-setting. It is a remote intervention that is delivered entirely over their phones. Participants will also receive a FitBit and electronic scale.

Experimental: Obese Low Risk
200 participants with BMI ≥30 and 10-year ASCVD risk <7.5%
Behavioral: Digital weight loss intervention
Participants with obesity enter into a proven 6 month weight loss program that utilizes health coaching and goal-setting. It is a remote intervention that is delivered entirely over their phones. Participants will also receive a FitBit and electronic scale.

No Intervention: Non-Obese High Risk
100 participants with BMI 18-25 and 10-year ASCVD risk ≥20%
No Intervention: Non-Obese Low Risk
100 participants with BMI 18-25 and 10-year ASCVD risk <7.5%



Primary Outcome Measures :
  1. Average branched-chain amino acid levels as measured by metabolomics analyses [ Time Frame: Baseline ]
  2. Change in branched-chain amino acid levels as measured by metabolomics analyses [ Time Frame: Baseline, End of intervention (up to 6 months) ]

Other Outcome Measures:
  1. Gut microbiome composition as measured by DNA sequencing [ Time Frame: Baseline ]
  2. Change in gut microbiome composition as measured by DNA sequencing [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  3. Genetic markers as measured by whole exome sequencing of DNA from saliva [ Time Frame: Baseline ]
  4. Impact of branched-chain amino acids on tissue engineered blood vessel function as measured by monocyte adhesion [ Time Frame: Baseline ]
  5. Impact of branched-chain amino acids on tissue engineered blood vessel function as measured by foam cell formation [ Time Frame: Baseline ]
  6. Change in impact of branched-chain amino acids on tissue engineered blood vessel function as measured by monocyte adhesion [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  7. Change in impact of branched-chain amino acids on tissue engineered blood vessel function as measured by foam cell formation [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  8. Average levels of inflammation measured by hs-CRP [ Time Frame: Baseline ]
  9. Change in average levels of inflammation measured by by hs-CRP [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  10. Average lipid profile as measured by total cholesterol [ Time Frame: Baseline ]
  11. Change in lipid profile as measured by total cholesterol [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  12. Average lipid profile as measured by HDL [ Time Frame: Baseline ]
  13. Change in lipid profile as measured by HDL [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  14. Average lipid profile as measured by LDL [ Time Frame: Baseline ]
  15. Change in lipid profile as measured by LDL [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  16. Average blood glucose control as measured by HbA1c [ Time Frame: Baseline ]
  17. Change in blood glucose control as measured by HbA1c [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  18. Average blood glucose control as measured by fasting glucose [ Time Frame: Baseline ]
  19. Change in blood glucose control as measured by fasting glucose [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  20. Average blood glucose control as measured by blood insulin level [ Time Frame: Baseline ]
  21. Change in blood glucose control as measured by blood insulin level [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  22. Average coronary artery calcium score as measured by CT testing [ Time Frame: Baseline ]
  23. Change in coronary artery calcium score as measured by CT testing [ Time Frame: Baseline, End of intervention (up to 6 months) ]
  24. Engagement as measured by percent of invitees viewing study-information page [ Time Frame: End of study, up to 2 years ]
  25. Best consent strategy as measured by percent of invitees signing the consent form [ Time Frame: End of study, up to 2 years ]
  26. Best consent strategy as measured by average score on Informed Consent Form comprehension quiz [ Time Frame: End of study, up to 2 years ]
    7 multiple choice questions, best outcome is 7/7 (100%), worst outcome is 0/7 (0%)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults 40-75 years old
  • At least one clinic encounter at Duke with BMI record in the EHR within previous year
  • Has a current primary care provider listed listed in EHR
  • No prior history of ASCVD, as defined by ICD9, ICD10, and CPT codes for coronary artery disease, myocardial infarction, stroke, peripheral arterial disease, prior revascularization for coronary, cerebral, or peripheral arteries.
  • Fall into 1 of 4 categories: 200 participants with obesity (BMI ≥ 30) and high 10-year ASCVD risk (≥20%), 200 participants with obesity (BMI ≥ 30) and low 10-year ASCVD risk (<7.5%), 100 participants with normal weight (BMI 18-25) and high 10-year ASCVD risk (≥20%), and 100 participants with normal weight (BMI 18-25) and low 10-year ASCVD risk (<7.5%).
  • Have internet access
  • Have an email address listed in the EHR
  • Have access to MyChart
  • Have a smartphone
  • Be able to read and understand English

Exclusion Criteria:

  • Participants "opted out" of being contacted for research in Maestro Care
  • Pregnant at the time of enrollment or <12 months post-partum
  • Prior bariatric surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04551872


Locations
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United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Neha Pagidipati, MD, MPH Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04551872    
Other Study ID Numbers: Pro00104664
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Obesity
Translating Duke Health
RESILIENCE
CVD
DUHS
Duke
Heart Disease
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight