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Understanding Obesity and Insulin Resistance in Youth

This study aims to understand how gut bacteria and digestion (colonic fermentation) affect metabolism in young people with obesity and insulin resistance. Researchers will give participants Lactulose Oral Product, which helps stimulate colonic fermentation, at the beginning and end of the 12-week study. They will measure changes in how fat is broken down (adipose tissue lipolysis) and how the body makes sugar (gluconeogenesis) to see how the intervention impacts these processes. You may be able to join if you are 15 to 22 years old, in puberty, and have a high Body Mass Index (BMI). The study is currently recruiting about 55 participants, but its exact status is unclear.

Study design
This is an interventional study with a planned enrollment of 55 participants. The study will involve giving Lactulose Oral Product to participants.
What's involved
You would receive Lactulose Oral Product at the beginning and end of the 12-week study. Measurements of adipose tissue lipolysis and gluconeogenesis will be taken at 6 hours, and adipose tissue lipolysis will also be measured at baseline and 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Measurements are taken at 6 hours and at 12 weeks, indicating a follow-up period of at least 12 weeks.

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NCT06768827

New Mechanisms of Obesity

Recruiting
NAAges 15–22InterventionalBasic science
Yale University
~55 participants
Updated 2026-01-28 on ClinicalTrials.gov
What's tested:Lactulose Oral Product

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CHANGES IN ADIPOSE TISSUE LIPOLYSIS (ATL)
Measured over 6 hours
+2 more outcomes measured

Conditions

Obesity and Overweight
Insulin Resistance
Obesity and Obesity-related Medical Conditions

Explore related trials

Insulin ResistanceObesity

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • NICOLA SANTORO, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

NICOLA SANTORO, MD, PhD
[email protected]
2037852819
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • CHANGES IN ADIPOSE TISSUE LIPOLYSIS (ATL)6 hours

    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.

  • CHANGES IN GLUCONEOGENESIS6 hours

    Gluconeogenesis (GLC) will be measured using change in deuterium oxide concentration after colonic fermentation due to lactulose ingestion and compared between OIS and OIR.

  • CHANGES IN ADIPOSE TISSUE LIPOLYSIS (ATL)Baseline and 12 weeks

    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.