Cardiovascular Diseases, Cognitive Impairment, Hepatic Steato-Fibrosis, Metabolic Disease, Obesity
Conditions
Keywords
obesity, multi-ethnicity, cardiovascular diseases, hepatic steatosis, metabolic diseases
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).
Interventions
None listed
Sponsors
King's College Hospital NHS Trust
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Men and women aged ≥18 years old * Body mass index (BMI) ≥ 30 kg/m2
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Height | 1 minute | Measured without shoes and reported in centimeters |
| Insulin resistance | 10 minutes | random plasma glucose, glycated haemoglobin (HbA1c) using a blood test |
| Type 2 Diabetes | 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). |
| 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. |
| 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. |
| Dyslipidemia | 10 minutes | Will be diagnosed from lipid levels reported in a blood test |
| 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 |
Countries
United Kingdom
Contacts
Primary ContactFannie Lajeunesse-Trempe, MD, Msc
Backup ContactGeorgios K. Dimitriadis, MD, PhD
Outcome results
None listed