Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study

Obesity Clinical Trial

— ACNH  

Official title:

Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study (ACNH Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06435611
• Other study ID #: 329603
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cognitive Impairment
• Metabolic Disease
• Metabolic Diseases
• Obesity

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