Clinical trial

New Mechanisms of Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT06768827

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age15 Years to 22 Years

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

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.

Treatments and study arms

Lactulose Oral Product

Other

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

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Yale University🇺🇸 New Haven, Connecticut, United States

Open map