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

NCT06435611 | Recruiting

• 1 other identifier: 329603
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Disease; Obesity; Hepatic Steato-Fibrosis; Cardiovascular Diseases; Cognitive Impairment

Keywords

obesity; multi-ethnicity; cardiovascular diseases; hepatic steatosis; metabolic diseases

Outcome Measures

Primary Outcomes (14)

• 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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Men and women aged ≥18 years old
• Body mass index (BMI) ≥ 30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (2)

King's College Hospital NHS Foundation Trust

London, United Kingdom of Great Britain and Northern Ireland, SE5 9RS, United Kingdom

ACTIVE NOT RECRUITING

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Metabolic Diseases; Obesity; Cardiovascular Diseases; Cognitive Dysfunction; Fatty Liver

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Liver Diseases; Digestive System Diseases

Study Officials

• Georgios K. Dimitriadis, PhD

  Kings College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fannie Lajeunesse-Trempe, MD, Msc

CONTACT

14384901454; fanny.lajeunesse-trempe.1@ulaval.ca

Georgios K. Dimitriadis, MD, PhD

CONTACT

g.dimitriadis@nhs.net

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist Consultant and Obesity Physician

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: May 30, 2024
• Study Start: November 15, 2023
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 1 year
• 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.

Locations

GB (2)