Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study (ACNH Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Height
研究概览
简要总结
The goal of this pilot and feasibility study is to is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at Kings College Hospital NHS Foundation Trust (KCH).
The main aim is to assess and compare anthropometric measurements of adiposity (weight, Body Mass Index (BMI), Waist Circumference (WC), Waist-to-Hip ratio (WHR), Neck circumference (NC)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background.
Participants will come at KCH for one visit and will have their anthropometric measurements and cardio-metabolic profile assessed. They will also perform questionnaires on lifestyle, socio-economic status and neuro-cognitive health during their visit.
详细描述
The first objective of this study is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at Kings College Hospital NHS Foundation Trust.
The second objective is to assess and compare anthropometric measurements of adiposity (weight, Body Mass Index (BMI), Waist Circumference (WC), Waist-to-Hip ratio (WHR), Neck circumference (NC)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background.
The third objective is to test the feasibility of assessing cognitive function, in relation to adiposity, by using standardised tests measuring cognitive function (MMSE, MoCA or an adapted version) among ethnic groups of various education levels and literacy, lifestyle and from different cultures. Our objective is also to test the feasibility of using lifestyle questionnaires [Food Frequencies Questionnaires (FFQ) and International Physical Activity Questionnaires -(IPAQ-S)] in various ethnic groups with regard to geographic variation (urban, rural).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged ≥18 years old
- •Body mass index (BMI) ≥ 30 kg/m2
排除标准
- •Severe obesity (BMI > 50 kg/m2)
- •Pregnancy (positive urine hCG) or a recent pregnancy (in the past 6 months)
- •Known active chronic hepatic diseases
- •Known diagnosis of human immunodeficiency virus
- •Pre-established diagnosis of advanced renal failure (estimated Glomerular Filtration Rate (eGFR) <30 ml/min)
- •Diagnosis of decompensated heart failure
- •History of bariatric surgery
- •Uncontrolled thyroid disease
- •Current use of the following medication: steroids (oral or injections only), weight-loss medication including over-the-counter products, glucagon-like peptide 1 (GLP-1) agonists , Sodium-Glucose Transport Protein 2 (SGLT2) Inhibitors
结局指标
主要结局
Height
时间窗: 1 minute
Measured without shoes and reported in centimeters
Waist circumference
时间窗: 1 minute
Will be measured with a tape around the middle point halfway between the top of the hips and the bottom of the ribs, at expiration. Will be reported in centimeters.
Hip circumference
时间窗: 1 minute
Will be measure with a tape around the widest part of the hips. Will be reported in centimeters.
Insulin resistance
时间窗: 10 minutes
random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
Hepatic steatosis, and stages of fibrosis
时间窗: 10 minutes
Assessed by a certified physician using transient elastography (TE) measurements using a Fibroscan (Model mini-430).
Dyslipidemia
时间窗: 10 minutes
Will be diagnosed from lipid levels reported in a blood test
Type 2 Diabetes
时间窗: 10 minutes
random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
neurocognitive risk factors
时间窗: 15 minutes
Result below 25 on the Montreal Cognitive Assessment test (MoCA). No minimum results, normal is above or equal to 26. The lower the result is the more the participant is at risk of presenting any form of neuro-cognitive impairment.
Weight
时间窗: 1 minute
Measured using an automatic scale, without shoes. Reported in kilograms.
BMI
时间窗: 30 seconds
Will be calculated from weight and height results and will be presented in kg/m2.
Neck circumference
时间窗: 1 minutes
Will be measure with a tape around a point just below the larynx (Adam's Apple) and perpendicular to the long axis of the neck. The participant should look straight ahead during measurement, with shoulders down (not hunched). Round the neck measurement up to nearest ½ centimeters. Result will be reported in centimeters.
Waist-to-Hip ratio
时间窗: 30 seconds
Will be derived from waist circumference and hip circumference.
Waist-to-Height ratio
时间窗: 30 seconds
Will be derived from waist circumference and height.
Hypertension (estimated using blood pressure measurement)
时间窗: 10minutes
blood pressure will consist of 3 systolic blood pressure and diastolic blood pressure measurements
次要结局
未报告次要终点
研究者
Georgios Dimitriadis
Endocrinologist Consultant and Obesity Physician
King's College Hospital NHS Trust