NCT05311462Active, not recruiting
An Observational Cohort Study to Obese Patients With Weight Cycling
Exploration on Prevention and Treatment Mechanism of Obese Patient With Weight Cycling: An Investigator-initiated Single-center Cohort Study
Source: ClinicalTrials.gov · Last updated 14 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 15 Mar 2022
- Start date
- 8 Apr 2022
- Primary completion date
- 20 Jan 2025
- Lead sponsor
- Peking Union Medical College Hospital
- Diseases
- Obesity
- NCT number
- NCT05311462
What you commit to
- Study type: Observational
- Planned participants: 180
- From 8 Apr 2022 to the primary completion date, 20 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.);
- Secondary obesity or drug obesity patients: including hypothalamic obesity, pituitary obesity, hypercortisolism, and hypogonadism obesity;
Other illness
- With serious eating disorders or vigorous exercise to lose weight;
- History of serious cardiovascular disease;
- Acute, chronic, or active gastrointestinal diseases;
- Serious systemic diseases;
- History of serious mental disorders;
- Cancer or active tumor;
Lab values
- 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);
Other
- Bodyweight has changed more than ±10% in the past year;
- Women who are currently pregnant or nearly 3 months breastfeeding;
- Hard physical workers;
- Those who are considered by the researcher to be poor compliance or unable to complete this research well.
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.