Clinical trial NCT06435611: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Disease
Obesity
Hepatic Steato-Fibrosis
Cardiovascular Diseases
Cognitive Impairment
Keywords: obesity
multi-ethnicity
cardiovascular diseases
hepatic steatosis
metabolic diseases
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult male and female living with obesity (BMI ≥ 30 kg/m2 )

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).

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

Primary outcomes:
measure: Height
timeFrame: 1 minute
measure: Insulin resistance
timeFrame: 10 minutes
measure: Type 2 Diabetes
timeFrame: 10 minutes
measure: Hepatic steatosis, and stages of fibrosis
timeFrame: 10 minutes
measure: neurocognitive risk factors
timeFrame: 15 minutes
measure: Weight
timeFrame: 1 minute
measure: BMI
timeFrame: 30 seconds
measure: Waist circumference
timeFrame: 1 minute
measure: Hip circumference
timeFrame: 1 minute
measure: Dyslipidemia
timeFrame: 10 minutes
measure: Neck circumference
timeFrame: 1 minutes
measure: Waist-to-Hip ratio
timeFrame: 30 seconds
measure: Waist-to-Height ratio
timeFrame: 30 seconds
measure: Hypertension (estimated using blood pressure measurement)
timeFrame: 10minutes
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: United Kingdom Of Great Britain And Northern Ireland
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
affiliation: Kings College Hospital
name: Georgios K. Dimitriadis, PhD
role: PRINCIPAL_INVESTIGATOR
References: