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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Obesity; Cognitive Impairment; Metabolic Disease; Hepatic Steato-Fibrosis

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).

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Fannie Lajeunesse-Trempe, MD, Msc; Phone Number: 14384901454; Email: fanny.lajeunesse-trempe.1@ulaval.ca
• Study Contact Backup: Name: Georgios K. Dimitriadis, MD, PhD; Email: g.dimitriadis@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital NHS Foundation Trust
    • Contact: Georgios K Dimitriadis; Phone Number: 00441689863091; Email: georgios.dimitriadis@kcl.ac.uk
  • United Kingdom Of Great Britain And Northern Ireland
    • London, United Kingdom Of Great Britain And Northern Ireland, United Kingdom, SE5 9RS
      • Active, not recruiting
      • King's College Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult male and female living with obesity (BMI ≥ 30 kg/m2 )

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Georgios K. Dimitriadis, PhD, Kings College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: May 24, 2024
• First Posted (Actual): May 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: obesity; cardiovascular diseases; metabolic diseases; hepatic steatosis; multi-ethnicity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases
• Other Study ID Numbers: 329603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared among different collaborative centers to compare outcomes among different ethnic groups from rural and urban environment of low- middle and high income countries.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: To have collected 10 participants (5 males and 5 females) as per protocol and have agreed on a specific data sharing agreement signed by all parties.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No