Metabolic DiseaseACNHNCT06435611
Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study
An observational study of Metabolic Disease and Obesity, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Metabolic Disease, Obesity, Hepatic Steato-Fibrosis
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Nov 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adult male and female living with obesity (BMI ≥ 30 kg/m2 )
Who may be able to join
- Men and women aged ≥18 years old
- Body mass index (BMI) ≥ 30 kg/m2
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Georgios K. Dimitriadis, MD, PhD contact
United Kingdom2 sites, 1 recruiting
- Active, not recruiting
King's College Hospital NHS Foundation Trust
London, United Kingdom of Great Britain and Northern Ireland, SE5 9RS
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Georgios K Dimitriadis, 00441689863091, georgios.dimitriadis@kcl.ac.uk
About this study
Official title: 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.
Read the 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
- Metabolic Disease, Obesity, Hepatic Steato-Fibrosis, Cardiovascular Diseases, Cognitive Impairment
- Keywords
- obesity, multi-ethnicity, cardiovascular diseases, hepatic steatosis, metabolic diseases
- Medical subject headings
- Metabolic Diseases, Obesity, Cardiovascular Diseases, Cognitive Dysfunction, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Measured without shoes and reported in centimeters
Measured: 1 minute
Insulin resistance
random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
Measured: 10 minutes
Type 2 Diabetes
random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
Measured: 10 minutes
Hepatic steatosis, and stages of fibrosis
Assessed by a certified physician using transient elastography (TE) measurements using a Fibroscan (Model mini-430).
Measured: 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.
Measured: 15 minutes
Weight
Measured using an automatic scale, without shoes. Reported in kilograms.
Measured: 1 minute
BMI
Will be calculated from weight and height results and will be presented in kg/m2.
Measured: 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.
Measured: 1 minute
Hip circumference
Will be measure with a tape around the widest part of the hips. Will be reported in centimeters.
Measured: 1 minute
Dyslipidemia
Will be diagnosed from lipid levels reported in a blood test
Measured: 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.
Measured: 1 minutes
Waist-to-Hip ratio
Will be derived from waist circumference and hip circumference.
Measured: 30 seconds
Waist-to-Height ratio
Will be derived from waist circumference and height.
Measured: 30 seconds
Hypertension (estimated using blood pressure measurement)
blood pressure will consist of 3 systolic blood pressure and diastolic blood pressure measurements
Measured: 10minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start15 Nov 2023
- Primary completion30 Dec 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Dimitriadis, King's College Hospital NHS Trust
- Investigators
- Georgios K. Dimitriadis, PhD, Principal investigator, Kings College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435611
- Sponsor's protocol ID
- 329603
- Acronym
- ACNH
- Status last verified
- May 2024
- First submitted
- 12 Jul 2023
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study (ACNH Study)
- ClinicalTrials.gov ID
- NCT06435611
- Acronym / sponsor ID
- ACNH / 329603
- Conditions
- Metabolic Disease, Obesity, Hepatic Steato-Fibrosis, Cardiovascular Diseases, Cognitive Impairment
- Keywords
- obesity, multi-ethnicity, cardiovascular diseases, hepatic steatosis, metabolic diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adult male and female living with obesity (BMI ≥ 30 kg/m2 )
Key inclusion criteria (2 listed)
- Men and women aged ≥18 years old
- Body mass index (BMI) ≥ 30 kg/m2
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Height
Time frame: 1 minute
Measured without shoes and reported in centimeters
Insulin resistance
Time frame: 10 minutes
random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
Type 2 Diabetes
Time frame: 10 minutes
random plasma glucose, glycated haemoglobin (HbA1c) using a blood test
Hepatic steatosis, and stages of fibrosis
Time frame: 10 minutes
Assessed by a certified physician using transient elastography (TE) measurements using a Fibroscan (Model mini-430).
neurocognitive risk factors
Time frame: 15 minutes
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.
Weight
Time frame: 1 minute
Measured using an automatic scale, without shoes. Reported in kilograms.
BMI
Time frame: 30 seconds
Will be calculated from weight and height results and will be presented in kg/m2.
Waist circumference
Time frame: 1 minute
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.
Hip circumference
Time frame: 1 minute
Will be measure with a tape around the widest part of the hips. Will be reported in centimeters.
Dyslipidemia
Time frame: 10 minutes
Will be diagnosed from lipid levels reported in a blood test
Neck circumference
Time frame: 1 minutes
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.
Waist-to-Hip ratio
Time frame: 30 seconds
Will be derived from waist circumference and hip circumference.
Waist-to-Height ratio
Time frame: 30 seconds
Will be derived from waist circumference and height.
Hypertension (estimated using blood pressure measurement)
Time frame: 10minutes
blood pressure will consist of 3 systolic blood pressure and diastolic blood pressure measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios K. Dimitriadis, MD, PhD contact
Georgios K. Dimitriadis, PhD principal investigator
Kings College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disease and Obesity, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fannie Lajeunesse-Trempe, MD, Msc (14384901454, fanny.lajeunesse-trempe.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: 1 minute). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.