Clinical trial

Adaptive Mechanisms Responsible for Weight Change in Youth With Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT05125822

Recruiting nowNot applicableInterventional

What this study is about

In this study, doctors want to find out more about why people who lose weight often regain the weight that they have lost once they resume a regular diet and whether hormones might play a role in weight regain. The study is divided into two parts, called the meal replacement period and the follow-up period. The meal replacement period will consist of drinking a shake for breakfast and lunch and eating a frozen meal for dinner that is calorie controlled. Individuals will also be asked to eat two servings of fruit and three servings of vegetables each day. The study will provide the shakes and the frozen entrees, participants are asked to supply the fruits and vegetables. Participation in this study will last for up to 35 weeks. There will be 10 in-person visits and 13 visits by phone or over Zoom over the 35 weeks.

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

Age11 Years to 15 Years

SexAll

Healthy volunteersNot accepted

ConditionChildhood Obesity

Full registry criteria

Inclusion Criteria: * 11 to less than 16 years old * BMI \> 30 kg/m\^2 or 95th BMI percentile * Tanner stage 2, 3, or 4 Exclusion Criteria: * Tanner stage 1 and 5 * Prior bariatric surgery * Current or recent (\< 3 months prior to enrollment) use of anti-obesity medication(s) defined as orlistat, metformin, phentermine, topiramate, combination phentermine/topiramate, liraglutide, and/or combination naltrexone/bupropion (monotherapy use of naltrexone or bupropion is not an exclusion) * Monogenic and hypothalamic obesity * Polycystic ovary syndrome (diagnosed by a physician) * Pregnancy or planned pregnancy * Current use of supplemental hormones * Individuals with a diagnosed eating disorder of anorexia nervosa, bulimia or binge eating disorder * Type 1 or 2 diabetes * Treatment with growth hormones * Thyroid disease/problem * Has had cancer in the last 10 years

Treatments and study arms

Meal replacement and lifestyle modification

Other

Meal replacement and lifestyle modification

Primary outcomes

Change in fat mass regain after initial weight loss with meal replacement therapy (MRT)17 weeks.

We hypothesize that the greater the initial weight loss with MRT the greater the fat mass regain at 26 weeks.

Change in ghrelin17 weeks.

We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone ghrelin.

Change in gastric inhibitory polypeptide17 weeks

We hypothesize that after the initial weight loss with MRT that we will see an increase in the level of the appetite regulating hormone gastric inhibitory polypeptide.

Study locations

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

Ann & Robert H Lurie Children's Hospital of Chicago🇺🇸 Chicago, Illinois, United States

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Justin R RyderContact

Email · Call 3148826838

Justin Ryder, PhDPrincipal Investigator