New Mechanisms of Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-22
SponsorYale University
About this trial
Given the pervasiveness of Pediatric Obesity, it is imperative to understand its pathophysiology and develop alternative strategies to reverse this condition. Herein, investigators propose to elucidate the interaction between colonic fermentation and insulin resistance in modulating metabolism in youth with obesity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 15 to 22 years
In puberty (girls and boys: Tanner stage III-V);
BMI >85th
Disqualifiers
Pregnancy;
endocrinopathies (e.g., Cushing syndrome);
substance abuse;
medications affecting insulin resistance such as metformin, GLP-1 analogues; -
Trial design
Design model
Parallel
Treatments tested in this trial
Lactulose Oral Product
Other interventionEach arm will undergo a study to induce colonic fermentation through lactulose at the beginning and at the end of the 12 weeks.
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: Remote physical exerciseExperimental treatment 1 intervention
Group B: Control physical exerciseActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
CHANGES IN ADIPOSE TISSUE LIPOLYSIS (ATL)
Changes in adipose tissue lipolysis occurring after colonic fermentation (stimulated by lactulose) will be compared between youth with obesity and insulin resistance (OIR) and with obesity and without insulin resistance (OIS). Lipolysis will be measured by using change in D5-glycerol concentration.
Time frame
6 hours2
CHANGES IN GLUCONEOGENESIS
Gluconeogenesis (GLC) will be measured using change in deuterium oxide concentration after colonic fermentation due to lactulose ingestion and compared between OIS and OIR.
Time frame
6 hours3
CHANGES IN ADIPOSE TISSUE LIPOLYSIS (ATL)
Changes in ATL due to colonic fermentation will be measured in two groups of OIR youth. One group will undergo physical activity for 12 weeks and another group will undergo a control intervention. Lipolysis will be measured by using change in D5-glycerol concentration.
Time frame
Baseline and 12 weeksSecondary outcomes
1
CHANGES IN PEPTIDE YY (PYY) concentration
Changes in PYY concentration after lactulose intervention will be compared between OIS and OIR.
Time frame
Baseline and 12 weeks2
CHANGES IN GHRELIN concentration
Changes in GHRELIN concentration after lactulose intervention will be compared between OIS and OIR.
Time frame
Baseline and 12 weeksSponsors and contacts
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Yale University
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov