Recruiting

Pediatric Obesity

Sponsor:

Yale University

Code:

NCT06768827

Conditions

Obesity and Overweight

Insulin Resistance

Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex: All

Age: 15 - 22

Healthy Volunteers: Not accepted

Interventions

Lactulose Oral Product

Study Details

Brief summary:

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.

Conditions

Obesity and Overweight

Insulin Resistance

Obesity and Obesity-related Medical Conditions

Study ID

NCT06768827

Start date

Nov 13, 2025

Status verified date

Jan, 2026

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 22

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 15 to 22 years
  • In puberty (girls and boys: Tanner stage III-V);
  • BMI >85th

Exclusion Criteria:

  • Pregnancy;
  • endocrinopathies (e.g., Cushing syndrome);
  • substance abuse;
  • medications affecting insulin resistance such as metformin, GLP-1 analogues; -
  • high fibers intake (> 30g/day) as assessed by a 3-day food record.

Study Design

Enrollment

55 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Remote physical exercise

active comparator: Control physical exercise

Interventions

Lactulose Oral Product

Each arm will undergo a study to induce colonic fermentation through lactulose at the beginning and at the end of the 12 weeks.

Primary outcome measure

  • CHANGES IN ADIPOSE TISSUE LIPOLYSIS (ATL) [ Time Frame: 6 hours ]
  • CHANGES IN GLUCONEOGENESIS [ Time Frame: 6 hours ]
  • CHANGES IN ADIPOSE TISSUE LIPOLYSIS (ATL) [ Time Frame: Baseline and 12 weeks ]

Central Contacts and Locations

Central contacts

NICOLA SANTORO, MD, PhD

2037852819nicola.santoro@yale.edu

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Jan 28, 2026

Last verified

Jan, 2026

Keywords

  • Obesity
  • Youth
  • Insulin Resistance
  • Intestinal Fermentation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-01-28.