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

NCT ID: NCT06435611

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-15

Study Completion Date

2024-06-30

Brief Summary

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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

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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

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Metabolic Disease Obesity Hepatic Steato-Fibrosis Cardiovascular Diseases Cognitive Impairment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Georgios Dimitriadis

Endocrinologist Consultant and Obesity Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Georgios K. Dimitriadis, PhD

Role: PRINCIPAL_INVESTIGATOR

Kings College Hospital

Locations

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King's College Hospital NHS Foundation Trust

London, United Kingdom of Great Britain and Northern Ireland, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

King's College Hospital NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Fannie Lajeunesse-Trempe, MD, Msc

Role: CONTACT

14384901454

Georgios K. Dimitriadis, MD, PhD

Role: CONTACT

Facility Contacts

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Georgios K Dimitriadis

Role: primary

00441689863091

Other Identifiers

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329603

Identifier Type: -

Identifier Source: org_study_id

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