Clinical Trial: Pediatric Obesity Observational Prospective Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Pediatric Obesity Observational Prospective Trial: Microbiome and Metabolism During Obesity Target Therapeutics

Brief Summary: Using an observational case-control cohort design, the investigator aims to define the mechanisms underlying microbiome regulation of metabolism in adolescence before and after medically indicated therapies for obesity. The investigator's overarching hypothesis is that gut bacteria control host weight, insulin sensitivity, and response to weight-loss treatments by modifying host metabolism.

Detailed Summary:

Intervention Cohorts: A prospective, longitudinal observational case control study will be performed. All subjects will receive Healthy Lifestyle Program (HLP) standard of care, which includes intensive lifestyle modification and free participation in Bull City Fit. Four groups of participants receiving obesity treatment will be enrolled: (1) HLP-only, (2) HLP + Low carbohydrate diet, (3) HLP + weight loss medication(s) and (4) HLP + Bariatric surgery. Consistent with the observational design of this study, study participants will be assigned to each group as per usual HLP clinical care, based on established standards and guidelines, expert medical provider recommendations, and family preference.

Comparison Cohort: two comparison groups be enrolled:(1c) healthy siblings of enrolled intervention subjects and (2c) age/sex matched controls recruited from the Duke Children's Primary Care Clinic.

Up to 350 participants will be enrolled, with the goal of 295 evaluable participant data. The study period is six months for all groups with the exception of the bariatric surgery group which will last from baseline until after surgery, up to 12 months. The comparison groups will have one visit at baseline only.

Stool Sample Collection: Participants in both intervention and comparison groups will provide a fecal sample at enrollment or within 3 days of enrollment. Participants in intervention groups (Groups 1-4) will provide additional fecal samples at 1.5, 3, 4.5, and 6 months. Given that the ability to collect fecal samples is unpredictable, the investigator will develop a standard operating procedure along the following guidelines:

  1. At the first visit, if the subject cannot provide a sample at the time o
    Sponsor: Duke University

    Current Primary Outcome: Change in Body Mass Index (kg/m2) [ Time Frame: Baseline and 6 months ]

    We will measure weight (in kilograms) and height (in cm) for all subjects at baseline and at 6 months (12 months for the surgery group). The between-group difference in Body Mass Index change will be reported.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change in blood pressure [ Time Frame: Baseline and 6 months ]
      Blood pressure will be measured at baseline and 6-months (12-months for the surgery group) using standard methods, and change in blood pressure between groups will be reported
    • Change in cardiovascular fitness [ Time Frame: Baseline and 6 months ]
      We will perform a 3-minute standardized stepping test at baseline and 6-months (12 months for surgery group) and compare between-group differences in heart rate change with step test.
    • Change in fasting blood cholesterol [ Time Frame: Baseline and 6 months ]
      We will measure fasting blood cholesterol at baseline and at 6-months (12 months for surgery group) and compare between-group differences in total cholesterol.
    • Change in fasting blood glucose [ Time Frame: Baseline and 6 months ]
      We will measure fasting blood glucose at baseline and at 6-months (12 months for surgery group) and compare between-group differences in fasting blood glucose.
    • Change in stool microbiota profile [ Time Frame: Baseline and every 6 weeks up to 6 months (0m, 1.5m, 3m, 4.5m, 6m) ]
      Fecal samples will be analyzed for the composition of the microbiota by extracting and sequencing the RNA from the organisms. We will report the communities of microbes at each time point.
    • Change in blood metabolites [ Time Frame: Baseline, 3 months and 6 months ]
      Blood samples will be analyzed for a panel of metabolites that may be produced by the intestinal microbiota. We will report the metabolic profiles at each time point.


    Original Secondary Outcome: Same as current

    Information By: Duke University

    Dates:
    Date Received: March 15, 2017
    Date Started: September 13, 2016
    Date Completion: December 31, 2020
    Last Updated: May 2, 2017
    Last Verified: February 2017