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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06435611
Other study ID # 329603
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2023
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source King's College Hospital NHS Trust
Contact Fannie Lajeunesse-Trempe, MD, Msc
Phone 14384901454
Email fanny.lajeunesse-trempe.1@ulaval.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 10
Est. completion date June 30, 2024
Est. primary completion date December 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Locations

Country Name City State
United Kingdom King's College Hospital NHS Foundation Trust London United Kingdom Of Great Britain And Northern Ireland
United Kingdom King's College Hospital NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Height Measured without shoes and reported in centimeters 1 minute
Primary Insulin resistance random plasma glucose, glycated haemoglobin (HbA1c) using a blood test 10 minutes
Primary Type 2 Diabetes random plasma glucose, glycated haemoglobin (HbA1c) using a blood test 10 minutes
Primary Hepatic steatosis, and stages of fibrosis Assessed by a certified physician using transient elastography (TE) measurements using a Fibroscan (Model mini-430). 10 minutes
Primary neurocognitive risk factors 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. 15 minutes
Primary Weight Measured using an automatic scale, without shoes. Reported in kilograms. 1 minute
Primary BMI Will be calculated from weight and height results and will be presented in kg/m2. 30 seconds
Primary Waist circumference 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. 1 minute
Primary Hip circumference Will be measure with a tape around the widest part of the hips. Will be reported in centimeters. 1 minute
Primary Dyslipidemia Will be diagnosed from lipid levels reported in a blood test 10 minutes
Primary Neck circumference 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. 1 minutes
Primary Waist-to-Hip ratio Will be derived from waist circumference and hip circumference. 30 seconds
Primary Waist-to-Height ratio Will be derived from waist circumference and height. 30 seconds
Primary Hypertension (estimated using blood pressure measurement) blood pressure will consist of 3 systolic blood pressure and diastolic blood pressure measurements 10minutes
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