Active — Not RecruitingNot Applicable

An Observational Cohort Study to Obese Patients With Weight Cycling

China180 participantsStarted 2022-04-08

Plain-language summary

Medical nutritional weight loss was effective in reducing body weight and waist circumference and improving a range of cardiovascular disease risk factors in obese patients, with an average effective weight loss of 11.1 kg (about 13%) over 4 months in obese adults. However, it was found through the follow-up visit that these subjects had lost only 5.8kg from baseline and regained about half of their weight (5.1 kg, 48%) after 21 months of weight-loss intervention. In this study, intestinal flora analysis was proposed to identify the causes of individual repeated weight loss failure, structure changes of weight cycling and the advantage species of flora, and explore different intestinal microbiota（microbial genomics） in ending weight loss, obesity-related genetic characteristics (SNPs loci and RNA seq), metabolite（metabolomics）and potential interaction between appetite-related hormones and weight cycling triggers. This study aimed to provide new insights for implementing personalized weight loss programs to improve the success rate of weight loss. The obese patients who failed to lose weight repeatedly were recruited from Peking Union Medical College Hospital. Research Contents:(1) Comparison of anthropometric, biochemical, energy consumption, and intestinal microbiota related indicators between groups; (2) Genotyping to screen out differential SNPs loci;(3) Analysis of the interaction between genes and environmental factors in different metabolic types of obesity. (4) A group of healthy volunteers with normal weight as the healthy control group.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Normal weight (18.5 ≤ BMI \< 24 kg/m2) or obese (28 ≤ BMI \< 35 kg/m2); * Aged 18 to 50 years old; * Han nationality; * Able to follow the weight-loss prescription; * Able to sign consent independently; * Definition of Weight cycling: Loss weight more than once in the past 3 years, and weight regain exceeds 5% or more of the baseline weight of losing weight. Exclusion Criteria: * Bodyweight has changed more than ±10% in the past year; * Taking drugs known to affect body weight (orlistat, GLP-1 receptor agonists, etc.); * Taking drugs known to affect glucolipid metabolism (such as sulfonylureas, biguanides, acarbose, or insulin) have been taken in the past 6 months or at present; Lipid-lowering drugs such as statins, bate, niacin, and ezetimibe; Diuretics, β -blockers and other antihypertensive drugs; Glucocorticoid, thyroid hormone, etc.); * Women who are currently pregnant or nearly 3 months breastfeeding; * With serious eating disorders or vigorous exercise to lose weight; * Hard physical workers; * History of serious cardiovascular disease; * Acute, chronic, or active gastrointestinal diseases; * Serious systemic diseases; * History of serious mental disorders; * Cancer or active tumor; * Secondary obesity or drug obesity patients: including hypothalamic obesity, pituitary obesity, hypercortisolism, and hypogonadism obesity; * Severe liver dysfunction (ALT, AST, ALP, and TBil \> the upper limit of 2.5 times reference value); * Chronic kidney diseas…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

BMI changes

Timeframe: Baseline time; after 1 months; after 45days; after 3 months; after 9 months；after1, 2, 3, 4 and 5 years

serum metabolome

Timeframe: Baseline time; after 9 months; after1, 2, 3, 4 and 5 years

Faecal metagenomes changes

Timeframe: Baseline time; after 45 days; after 3 months; after 9 months;after1, 2, 3, 4 and 5 years

transcriptome changes

Timeframe: Baseline time; after 3 months;after1, 2, 3, 4 and 5 years

Trial details

NCT IDNCT05311462

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-20

View on ClinicalTrials.gov More Weight Cycling trials