Official Title
Exploration on Prevention and Treatment Mechanism of Obese Patient With Weight Cycling: An Investigator-initiated Single-center Cohort Study
Brief Title
An Observational Cohort Study to Obese Patients With Weight Cycling
Protocol ID
NCT05311462
Lead Sponsor
Peking Union Medical College Hospital
Brief 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.
Study Period
-
Enrollment Count
180 participants
Eligibility Criteria
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 disease (eGFR < 60 mL/min/1.73 m2 or eGFR < 90 mL/min/1.73 m2 with
proteinuria);
- Those who are considered by the researcher to be poor compliance or unable to
complete this research well.
Filters
Weight Cycling
Obesity
ACTIVE_NOT_RECRUITING
ADULT