Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study
- Conditions
- Hepatic Steato-FibrosisCognitive ImpairmentMetabolic DiseaseObesityCardiovascular Diseases
- Registration Number
- NCT06435611
- Lead Sponsor
- King's College Hospital NHS Trust
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Men and women aged ≥18 years old
- Body mass index (BMI) ≥ 30 kg/m2
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Waist circumference 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 1 minute Will be measure with a tape around the widest part of the hips. Will be reported in centimeters.
Insulin resistance 10 minutes random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
Hepatic steatosis, and stages of fibrosis 10 minutes Assessed by a certified physician using transient elastography (TE) measurements using a Fibroscan (Model mini-430).
Dyslipidemia 10 minutes Will be diagnosed from lipid levels reported in a blood test
Height 1 minute Measured without shoes and reported in centimeters
Type 2 Diabetes 10 minutes random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
neurocognitive risk factors 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 1 minute Measured using an automatic scale, without shoes. Reported in kilograms.
BMI 30 seconds Will be calculated from weight and height results and will be presented in kg/m2.
Neck circumference 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 30 seconds Will be derived from waist circumference and hip circumference.
Waist-to-Height ratio 30 seconds Will be derived from waist circumference and height.
Hypertension (estimated using blood pressure measurement) 10minutes blood pressure will consist of 3 systolic blood pressure and diastolic blood pressure measurements
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
King's College Hospital NHS Foundation Trust
🇬🇧London, United Kingdom