Disorders Hidden Under the Guise of BMI - Metabolic Obesity in People With Normal Body Weight (MONW) - the Search for Diagnostic Markers and Its Consequences for Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Brachial Artery Flow-Mediated Dilation (FMD)
研究概览
简要总结
Metabolically Obese Normal Weight (MONW) represents a phenotype affecting individuals with a normal Body Mass Index (BMI) but characterized by excessive adipose tissue accumulation. This condition is associated with increased cardiovascular risk, insulin resistance, and endothelial dysfunction, yet remains underdiagnosed.
This observational longitudinal study aims to comprehensively evaluate the relationship between excessive adipose tissue deposition, endothelial dysfunction, and asprosin concentrations in young women. The study will recruit 176 healthy women aged 18-35 years with normal BMI (<25 kg/m²). Participants will be divided into two groups based on body fat percentage (PBF) assessed by dual-energy X-ray absorptiometry (DXA): the MONW group (PBF ≥ 35.78%) and the Control group (PBF < 35.78%).
The specific objectives of the study include:
- Assessment of vascular endothelial function using flow-mediated dilation (FMD) of the brachial artery.
- Evaluation of asprosin as a novel biomarker in the MONW phenotype.
- Analysis of biochemical indices including asymmetric dimethylarginine (ADMA) and von Willebrand factor (vWF).
- Advanced metabolomic profiling to identify metabolic signatures.
Participants will undergo anthropometric measurements, body composition analysis (DXA), and blood sampling for biochemical and hormonal analyses. The study aims to develop predictive models for early cardiovascular risk detection in normal-weight individuals.
详细描述
Study Design and Population:
This is a longitudinal observational study involving 176 healthy women aged 18-35 years. The primary aim is to identify diagnostic markers for Metabolically Obese Normal Weight (MONW) individuals. Recruitment is conducted via digital prescreening and university networks. Eligible participants must have a normal BMI (18.5-24.9 kg/m²) and stable body weight.
Group Allocation:
Participants will be divided into two groups based on Body Fat Percentage (PBF) assessed by Dual-Energy X-ray Absorptiometry (DXA):
- MONW Group: BMI < 25 kg/m² and PBF ≥ 35.78% (threshold derived from pilot population studies).
- Control Group: BMI < 25 kg/m² and PBF < 35.78%.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Written, informed consent to participate in the research.
- •Gender: Female.
- •Age 18-35 years.
- •BMI in the range of 18.5-25 kg/m².
排除标准
- •Thyroid disease.
- •Pregnancy or breastfeeding.
- •Eating disorders.
- •Polycystic ovary syndrome (PCOS).
- •Hormone therapy and/or use of hormonal contraceptives.
- •Metal or silicone implants (contraindication for DXA/body composition accuracy).
- •Vitamin and/or mineral supplementation.
- •Acute and/or chronic illnesses.
- •Type I or II diabetes, dyslipidemia, hypertension.
- •Use of hypolipemic, antihypertensive, antiglycemic, or insulin medications.
研究组 & 干预措施
MONW Group
Women with normal BMI (<25 kg/m²) and excessive body fat percentage (PBF ≥ 35.78%).
Control Group
Women with normal BMI (<25 kg/m²) and normal body fat percentage (PBF < 35.78%).
结局指标
主要结局
Brachial Artery Flow-Mediated Dilation (FMD)
时间窗: Baseline, 12 months
Assessment of vascular endothelial function using high-resolution ultrasound (Alpinion Xcube 90). FMD is calculated as the percentage change in vessel diameter from baseline to peak dilation following 5-minute occlusion cuff release.
次要结局
- Serum Asprosin Concentration(Baseline, 12 months)
研究者
Waldemar Pluta
Principal Investigator
Pomeranian Medical University Szczecin