Status:
UNKNOWN
Metabolic Optimization Through Diet/Lifestyle Improvements For Youth
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
University of California, Davis
NutritionQuest
Conditions:
Dyslipidemias
Obesity
Eligibility:
All Genders
10+ years
Phase:
NA
Brief Summary
The overarching goal of this study is to evaluate plasma ceramides (Cers) as early nutrition-sensitive biomarkers of metabolic health. The investigators will implement a diet and lifestyle interventio...
Detailed Description
Dysregulated sphingolipid ceramide (Cer) metabolism impairs mitochondrial function, insulin sensitivity and vascular reactivity and has been identified as a central common pathway towards the dyslipid...
Eligibility Criteria
Inclusion
- Adolescent inclusion criteria:
- Aged 10 years to 18 years Dyslipidemia (TG/HDL-c \>2.5 in non-Black males and \>2.0 in females and Black males) Central adiposity (waist to height ratio \> 0.5) Willingness to participate
- Adult inclusion criteria:
- Parent or adult caregiver of adolescent patient Central adiposity (waist to height ratio \>0.5) Willingness to participate
- Exclusion criteria (adolescent and parent) include
- Diabetes, genetic syndrome, stage II hypertension (systolic or diastolic BP \> 95th percentile for age, sex, and height percentile + 12mm Hg or \> 140/90, whichever is lower for subjects \< 13 yr of age, \> 140/90 for all \> 13 yr of age, including PAC; history of hypertension controlled on stable medication regimen accepted)
- Medication use known to affect insulin sensitivity or lipid profiles, including metformin, statins, fibric acids or second generation atypical anti-psychotics (stable doses of stimulant or antidepressant therapy accepted)
- Current participation and unwillingness to cease activities related to a diet/exercise lifestyle modification program other than this program
- Any medical condition or syndrome with neurocognitive delay that would preclude active participation with the mobile health app
- Pregnancy or intention to become pregnant (as this will alter weight distribution)
- Inability to participate in moderate physical activity
Exclusion
Key Trial Info
Start Date :
September 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04270084
Start Date
September 29 2020
End Date
December 31 2022
Last Update
February 7 2022
Active Locations (1)
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1
Childrens National Hospital
Washington D.C., District of Columbia, United States, 20010