## Protocol Section
### Identification Module
**NCT ID:** NCT06435611

**Acronym:** ACNH

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

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

#### Organization Study ID Info
**ID:** 329603
#### Organization
**Class:** OTHER
**Full Name:** King's College Hospital NHS Trust
### Status Module
#### Completion Date
**Date:** 2024-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2023-12-30

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-07-12
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** King's College Hospital NHS Trust

#### Responsible Party

**Investigator Affiliation:** King's College Hospital NHS Trust

**Investigator Full Name:** Georgios Dimitriadis

**Investigator Title:** Endocrinologist Consultant and Obesity Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Metabolic Disease

- Obesity

- Hepatic Steato-Fibrosis

- Cardiovascular Diseases

- Cognitive Impairment

**Keywords:**

- obesity

- multi-ethnicity

- cardiovascular diseases

- hepatic steatosis

- metabolic diseases

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Measured without shoes and reported in centimeters

**Measure:** Height

**Time Frame:** 1 minute

**Description:** random plasma glucose, glycated haemoglobin (HbA1c) using a blood test

**Measure:** Insulin resistance

**Time Frame:** 10 minutes

**Description:** random plasma glucose, glycated haemoglobin (HbA1c) using a blood test

**Measure:** Type 2 Diabetes

**Time Frame:** 10 minutes

**Description:** Assessed by a certified physician using transient elastography (TE) measurements using a Fibroscan (Model mini-430).

**Measure:** Hepatic steatosis, and stages of fibrosis

**Time Frame:** 10 minutes

**Description:** 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.

**Measure:** neurocognitive risk factors

**Time Frame:** 15 minutes

**Description:** Measured using an automatic scale, without shoes. Reported in kilograms.

**Measure:** Weight

**Time Frame:** 1 minute

**Description:** Will be calculated from weight and height results and will be presented in kg/m2.

**Measure:** BMI

**Time Frame:** 30 seconds

**Description:** 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.

**Measure:** Waist circumference

**Time Frame:** 1 minute

**Description:** Will be measure with a tape around the widest part of the hips. Will be reported in centimeters.

**Measure:** Hip circumference

**Time Frame:** 1 minute

**Description:** Will be diagnosed from lipid levels reported in a blood test

**Measure:** Dyslipidemia

**Time Frame:** 10 minutes

**Description:** 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.

**Measure:** Neck circumference

**Time Frame:** 1 minutes

**Description:** Will be derived from waist circumference and hip circumference.

**Measure:** Waist-to-Hip ratio

**Time Frame:** 30 seconds

**Description:** Will be derived from waist circumference and height.

**Measure:** Waist-to-Height ratio

**Time Frame:** 30 seconds

**Description:** blood pressure will consist of 3 systolic blood pressure and diastolic blood pressure measurements

**Measure:** Hypertension (estimated using blood pressure measurement)

**Time Frame:** 10minutes

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 55 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** Adult male and female living with obesity (BMI ≥ 30 kg/m2 )

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** fanny.lajeunesse-trempe.1@ulaval.ca

**Name:** Fannie Lajeunesse-Trempe, MD, Msc

**Phone:** 14384901454

**Role:** CONTACT

**Contact 2:**

**Email:** g.dimitriadis@nhs.net

**Name:** Georgios K. Dimitriadis, MD, PhD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** London

**Country:** United Kingdom

**Facility:** King's College Hospital NHS Foundation Trust

**State:** United Kingdom Of Great Britain And Northern Ireland

**Status:** ACTIVE_NOT_RECRUITING

**Zip:** SE5 9RS

**Location 2:**

**City:** London

**Contacts:**

***Contact 1:***

- **Email:** georgios.dimitriadis@kcl.ac.uk

- **Name:** Georgios K Dimitriadis

- **Phone:** 00441689863091

- **Role:** CONTACT

**Country:** United Kingdom

**Facility:** King's College Hospital NHS Foundation Trust

**Status:** RECRUITING

**Zip:** SE5 9RS

#### Overall Officials

**Official 1:**

**Affiliation:** Kings College Hospital

**Name:** Georgios K. Dimitriadis, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**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.

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** 1 year

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M29705

- Name: Cognitive Dysfunction

- Relevance: LOW

- As Found: Unknown

- ID: M11639

- Name: Metabolic Diseases

- Relevance: HIGH

- As Found: Metabolic Diseases

- ID: M8375

- Name: Fatty Liver

- Relevance: LOW

- As Found: Unknown

- ID: M8485

- Name: Fibrosis

- Relevance: LOW

- As Found: Unknown

- ID: T5868

- Name: Visceral Steatosis

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008659

- Term: Metabolic Diseases

### Misc Info Module

- Version Holder: 2024-05-31
