An Observational Cohort Study to Obese Patients With Weight Cycling

NCT ID: NCT05311462

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2028-12-20

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.

Conditions

Weight Cycling; Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Weight-loss success with history of weight cycling

High-protein diet for three months

No interventions assigned to this group

Weight-loss failure with history of weight cycling

High-protein diet for three months

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Li W, Wang D, Chen H, Liu Y, Dong S, Sun M, Chen W. The relationship between psychological distress and weight maintenance in weight cycling: mediating role of eating behavior. BMC Public Health. 2024 Mar 26;24(1):894. doi: 10.1186/s12889-024-18349-5.

Reference Type: DERIVED

PMID: 38532390 (View on PubMed)

Other Identifiers

K3171

Identifier Type: -

Identifier Source: org_study_id