Cardiovascular DiseasesNCT04646408
Determinants of Cardiovascular Disease, Kidney Disease and Diabetes
An observational study of Cardiovascular Diseases and Diabetes Mellitus, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
Cardiovascular disease (CVD), chronic kidney disease (CKD), diabetes mellitus (DM) and HIV infection are long-term conditions (LTC) with major health implications for people of African ancestry. Read more about this study
- Who is it for?
- Ages 18 months to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Diabetes Mellitus, Chronic Kidney Diseases
- How many people
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2020to 1 Oct 2022
- 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 months to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants will be sampled from an existing cohort from the GEN AFRICA (Genetics Markers of Kidney Disease Progression in People of African Heritage Study). 75 participants with CKD, 75 participants with diabetes, 50 participants with a history of ischaemic heart (IHD)disease/stroke and 200 participants without CKD, diabetes, IHD/stroke will be recruited.
Who may be able to join
- Having previously participated in the GEN-AFRICA study
- Aged 18-60 years
Who cannot join
- Not having participated in the GEN-AFRICA study
- Aged >60 years
Trial locations and contacts
1 site in 1 country.
Frank Post, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
King's College London
London, Apartment G02, Cordage House, SE59RS
Rachel Hung, MSc, 07894346851, rachel.hung@kcl.ac.uk
Frank Post, PhD, frank.post@kcl.ac.uk
About this study
Official title: Determinants of Cardiovascular Disease, Kidney Disease and Diabetes in People of African Ancestry With HIV (CKD Study)
Cardiovascular disease (CVD), chronic kidney disease (CKD), diabetes mellitus (DM) and HIV infection are long-term conditions (LTC) with major health implications for people of African ancestry. These LTC often arise in the setting of an adverse demographic, social, biologic and genetic environment, although this remains poorly understood.
The investigators plan to conduct a comprehensive syndemic evaluation in individuals with and without CVD, CKD and DM in people of African ancestry with HIV to obtain novel insights into the development of LTC in this population. In addition, the investigators will conduct focus groups to explore the role of syndemic factors in the development of LTC and develop and pilot an educational programme to improve knowledge about LTC in the African/Caribbean community.
Read the detailed description
Black African/Caribbean Communities in South London are disproportionally affected by long-term conditions (LTC), with a higher prevalence and an earlier onset (by about 13 years) (1). This population experiences high rates of hypertension, obesity, diabetes mellitus (DM), chronic kidney disease (CKD), cardiovascular disease (CVD) including stroke, social deprivation, poor housing, and mental health conditions such as anxiety and depression (1). HIV infection is also considerably more common in Black African/Caribbean Communities in South London than in the general UK population (2,3) and gives rise to stigma and discrimination, low self-esteem, dysfunctional relationships and loneliness (4).
The relationship between hypertension, obesity, metabolic syndrome, diabetes mellitus and CKD is well recognised. In this population, 'hypertensive nephropathy' is about 10-fold more common than in Caucasians, with earlier onset of end stage kidney disease (ESKD) (5). Although hypertensive nephropathy in people of African ancestry was previously attributed to resistant hypertension, exacerbated by poor engagement with health care services and suboptimal adherence to antihypertensive therapy, there is emerging evidence of strong genetic susceptibility to CKD as a result of prevalent mutations in the apolipoprotein L1 (APOL1), glutathione-S-transferase-μ1 (GSTM1) genes or sickle cell trait (SCT) (6-12). However, despite their strong associations with CKD, many individuals with these genetic variants do not develop kidney disease, suggesting that additional (i) biologic (e.g. coinfections, inflammation), (ii) environmental factors (e.g. obesity, diabetes), and (iii) socio-economic aspects, (e.g. inadequate health care access, stigma) may contribute to the development or progression of CKD although this has not been well studied.
There is growing recognition of the important role of social determinants of health (SDH) and its impact across a wide range of health indicators, settings, and populations (13,14). The World Health Organization (WHO) refers to SDH as conditions to which people are born, grow, work, live and age, linked to personal circumstances and systems (e.g. social, economic and political policies/heath care systems) that influences their daily lives (15-16). The new conceptual framework of syndemics provide an opportunity to study diseases and health conditions in populations that are deepened by the social, economic, environmental and political environment of a given population (17). The definition of a syndemic is 'the presence of two or more disease states (anchored around a core disease, in our case HIV) that adversely interact with each other, negatively affecting the mutual course of each disease trajectory, enhance vulnerability, and which are more harmful by experienced inequities' (18). This approach of a so-called 'syndemic lens' may be helpful in our study to identify the associations between genetic, biologic and social factors that contribute to the development of CKD and DM in people with hypertension, obesity, sub-clinical CKD and/or metabolic syndrome. This systemic approach can offer a new understanding of diseases that can improve public health and treat individual patients at the same time (19).
South London has a large (>200,000) population of African and Caribbean ancestry who are disproportionally affected by HIV and experience a higher burden of CKD, DM and other LTC, often with earlier onset compared to white populations. The investigators aim to study the demographic, clinical, social and genetic factors that associate with CKD, DM and multiple LTC in people with HIV. CKD and DM are key LTC that associate with hypertension, obesity and cardiovascular disease, resulting in or contribute to functional impairment, polypharmacy and impaired bio-psycho-social health outcomes.
The HIV clinics in South London provide a unique opportunity to access a diverse African and Caribbean population of working age in whom LTC can be studied. People with HIV from black African/Caribbean communities experience a high degree of social and economic deprivation, stigma, anxiety and depression which are considered important syndemic factors in the development of LTC. CKD and DM are common LTC, highly relevant to the black population, and relatively early events in the development of multiple and disabling LTC, thus identifying a population for targeted interventions that may reduce the rate of progression from a single to multiple LTC.
HIV infection, itself a LTC, can be effectively controlled with antiretroviral therapy, affording normal life expectancy and interrupting onward transmission. Routine care includes 6-12 monthly assessments for other LTCs, providing opportunities for recruitment of well characterised populations unselected for specific co-morbid conditions.
No studies to date in the UK have examined the contribution of biologic, clinical, social and genetic factors to the development of LTC in African/Caribbean populations with HIV to date. The team will generate detailed information on factors that associate with CKD, DM, CVD and multiple LTC as well as hypertension, sub-clinical CKD, obesity and insulin resistance, which often precede the development of CKD, DM and other LTC in this population. This study is likely to identify novel associations which can be confirmed and further explored in subsequent studies of HIV positive and general African/Caribbean populations. Stored biological samples will allow us to explore pathogenetic mechanisms in subsequent studies.
Key barriers to uptake of existing and novel interventions include low literacy levels, low perception of quality of life, lack of knowledge of LTCs, etc. The investigators will explore how best to overcome these barriers in focus groups and develop a culturally sensitive educational programme, aiming to reach individuals in communities that tend to poorly engage with health care and preventive programmes.
- Keywords
- chronic kidney disease, cardiovascular disease, HIV, syndemic, diabetes
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with CKD | Recruitment is from a cohort of HIV positive individuals of African ancestry with Chronic Kidney Disease CKD defined as eGFR <60 mL/min/1.73m2, and/or albumin/creatinine ratio >30 mg/mmol or protein/creatinine ratio >50 mg/mmol Anticipated n=75 | |
| Participants with diabetes | Recruitment is from a cohort of HIV positive individuals of African ancestry with diabetes. Diabetes is defined as being on diabetic medications or HbA1c >48 mmol/mol. Anticipated n=75 | |
| Participants with ischaemic heart disease/stroke | Recruitment is from a cohort of HIV positive individuals of African ancestry with previous ischaemic heart disease or stroke Anticipated n=50 | |
| No CKD/DM/CVD cohort | Recruitment is from a cohort of HIV positive individuals of African ancestry who do not have CKD, diabetes or prior ischaemic heart disease/stroke. Anticipated n=200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Obsity
- To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these:
- Obesity
Measured: 24months
Hypertension
- To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 2. Hypertension
Measured: 24months
CKD
- To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 3. CKD
Measured: 24months
Metabolic Syndrome
- To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 4. Metabolic syndrome
Measured: 24months
Syndemic aspects and qualitative assessment of contextual factors associated with long term health conditions
- To explore more subtle variations of contextual factors and experiences about the role of syndemic aspects and provide further insights that may have been missed by the "itemised" quantitative approach in outcome 1. (using validated tools such as DISCUS, HADS, EQ-5D-5L)
Measured: 24months
Educational
- To develop and pilot an educational programme on an existing App to improve knowledge about CKD, DM and CVD in the local African/Caribbean community.
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start1 Oct 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646408
- Sponsor's protocol ID
- KingCKD
- Status last verified
- Aug 2020
- First submitted
- 9 Sep 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
1. GSTT Charity report: From one to many. Exploring people's progression to multiple longterm conditions in an urban environment. Guy's and St. Thomas' Charity, London, July 2018. p10. 2. Public Health England. HIV in the UK 2016 report.
2. Public Health England. HIV in the UK 2016 report. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment _data/file/602942/HIV_in_the_UK_report.pdf
3. Public Health England. Hepatitis B in London 2016 data. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment _data/file/801174/London_hepatitis_B_report_2016.pdf
4. Public Health England. Positive Voices: The National Survey of People Living with HIV. Findings from the 2017 Survey. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/857922/PHE_positive_voices_report_2019.pdf
Saran R, Li Y, Robinson B, Abbott KC, Agodoa LY, Ayanian J, Bragg-Gresham J, Balkrishnan R, Chen JL, Cope E, Eggers PW, Gillen D, Gipson D, Hailpern SM, Hall YN, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Kalantar-Zadeh K, Kovesdy CP, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, Nguyen DV, O'Hare AM, Plattner B, Pisoni R, Port FK, Rao P, Rhee CM, Sakhuja A, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, White S, Woodside K, Hirth RA. US Renal Data System 2015 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2016 Mar;67(3 Suppl 1):Svii, S1-305. doi: 10.1053/j.ajkd.2015.12.014. No abstract available.
PubMed 26925525Kopp JB, Nelson GW, Sampath K, Johnson RC, Genovese G, An P, Friedman D, Briggs W, Dart R, Korbet S, Mokrzycki MH, Kimmel PL, Limou S, Ahuja TS, Berns JS, Fryc J, Simon EE, Smith MC, Trachtman H, Michel DM, Schelling JR, Vlahov D, Pollak M, Winkler CA. APOL1 genetic variants in focal segmental glomerulosclerosis and HIV-associated nephropathy. J Am Soc Nephrol. 2011 Nov;22(11):2129-37. doi: 10.1681/ASN.2011040388. Epub 2011 Oct 13.
PubMed 21997394Tin A, Scharpf R, Estrella MM, Yu B, Grove ML, Chang PP, Matsushita K, Kottgen A, Arking DE, Boerwinkle E, Le TH, Coresh J, Grams ME. The Loss of GSTM1 Associates with Kidney Failure and Heart Failure. J Am Soc Nephrol. 2017 Nov;28(11):3345-3352. doi: 10.1681/ASN.2017030228. Epub 2017 Jul 18.
PubMed 28720685Lipkowitz MS, Freedman BI, Langefeld CD, Comeau ME, Bowden DW, Kao WH, Astor BC, Bottinger EP, Iyengar SK, Klotman PE, Freedman RG, Zhang W, Parekh RS, Choi MJ, Nelson GW, Winkler CA, Kopp JB; SK Investigators. Apolipoprotein L1 gene variants associate with hypertension-attributed nephropathy and the rate of kidney function decline in African Americans. Kidney Int. 2013 Jan;83(1):114-20. doi: 10.1038/ki.2012.263. Epub 2012 Jul 25.
PubMed 22832513Genovese G, Friedman DJ, Ross MD, Lecordier L, Uzureau P, Freedman BI, Bowden DW, Langefeld CD, Oleksyk TK, Uscinski Knob AL, Bernhardy AJ, Hicks PJ, Nelson GW, Vanhollebeke B, Winkler CA, Kopp JB, Pays E, Pollak MR. Association of trypanolytic ApoL1 variants with kidney disease in African Americans. Science. 2010 Aug 13;329(5993):841-5. doi: 10.1126/science.1193032. Epub 2010 Jul 15.
PubMed 20647424Chang J, Ma JZ, Zeng Q, Cechova S, Gantz A, Nievergelt C, O'Connor D, Lipkowitz M, Le TH. Loss of GSTM1, a NRF2 target, is associated with accelerated progression of hypertensive kidney disease in the African American Study of Kidney Disease (AASK). Am J Physiol Renal Physiol. 2013 Feb 15;304(4):F348-55. doi: 10.1152/ajprenal.00568.2012. Epub 2012 Dec 5.
PubMed 23220723Naik RP, Derebail VK, Grams ME, Franceschini N, Auer PL, Peloso GM, Young BA, Lettre G, Peralta CA, Katz R, Hyacinth HI, Quarells RC, Grove ML, Bick AG, Fontanillas P, Rich SS, Smith JD, Boerwinkle E, Rosamond WD, Ito K, Lanzkron S, Coresh J, Correa A, Sarto GE, Key NS, Jacobs DR, Kathiresan S, Bibbins-Domingo K, Kshirsagar AV, Wilson JG, Reiner AP. Association of sickle cell trait with chronic kidney disease and albuminuria in African Americans. JAMA. 2014 Nov 26;312(20):2115-25. doi: 10.1001/jama.2014.15063.
PubMed 25393378Naik RP, Irvin MR, Judd S, Gutierrez OM, Zakai NA, Derebail VK, Peralta C, Lewis MR, Zhi D, Arnett D, McClellan W, Wilson JG, Reiner AP, Kopp JB, Winkler CA, Cushman M. Sickle Cell Trait and the Risk of ESRD in Blacks. J Am Soc Nephrol. 2017 Jul;28(7):2180-2187. doi: 10.1681/ASN.2016101086. Epub 2017 Mar 9.
PubMed 28280138Braveman P, Gottlieb L. The social determinants of health: it's time to consider the causes of the causes. Public Health Rep. 2014 Jan-Feb;129 Suppl 2(Suppl 2):19-31. doi: 10.1177/00333549141291S206.
PubMed 24385661Braveman P, Egerter S, Williams DR. The social determinants of health: coming of age. Annu Rev Public Health. 2011;32:381-98. doi: 10.1146/annurev-publhealth-031210-101218.
PubMed 21091195Social Determinants of Health. World Health Organization (WHO).
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Cardiovascular Disease, Kidney Disease and Diabetes in People of African Ancestry With HIV (CKD Study)
- ClinicalTrials.gov ID
- NCT04646408
- Acronym / sponsor ID
- KingCKD
- Keywords
- chronic kidney disease, cardiovascular disease, HIV, syndemic, diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 30 Nov 2020 (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.
Cardiovascular disease (CVD), chronic kidney disease (CKD), diabetes mellitus (DM) and HIV infection are long-term conditions (LTC) with major health implications for people of African ancestry. These LTC often arise in the setting of an adverse demographic, social, biologic and genetic environment, although this remains poorly understood.
The investigators plan to conduct a comprehensive syndemic evaluation in individuals with and without CVD, CKD and DM in people of African ancestry with HIV to obtain novel insights into the development of LTC in this population. In addition, the investigators will conduct focus groups to explore the role of syndemic factors in the development of LTC and develop and pilot an educational programme to improve knowledge about LTC in the African/Caribbean community.
Detailed description
Black African/Caribbean Communities in South London are disproportionally affected by long-term conditions (LTC), with a higher prevalence and an earlier onset (by about 13 years) (1). This population experiences high rates of hypertension, obesity, diabetes mellitus (DM), chronic kidney disease (CKD), cardiovascular disease (CVD) including stroke, social deprivation, poor housing, and mental health conditions such as anxiety and depression (1). HIV infection is also considerably more common in Black African/Caribbean Communities in South London than in the general UK population (2,3) and gives rise to stigma and discrimination, low self-esteem, dysfunctional relationships and loneliness (4).
The relationship between hypertension, obesity, metabolic syndrome, diabetes mellitus and CKD is well recognised. In this population, 'hypertensive nephropathy' is about 10-fold more common than in Caucasians, with earlier onset of end stage kidney disease (ESKD) (5). Although hypertensive nephropathy in people of African ancestry was previously attributed to resistant hypertension, exacerbated by poor engagement with health care services and suboptimal adherence to antihypertensive therapy, there is emerging evidence of strong genetic susceptibility to CKD as a result of prevalent mutations in the apolipoprotein L1 (APOL1), glutathione-S-transferase-μ1 (GSTM1) genes or sickle cell trait (SCT) (6-12). However, despite their strong associations with CKD, many individuals with these genetic variants do not develop kidney disease, suggesting that additional (i) biologic (e.g. coinfections, inflammation), (ii) environmental factors (e.g. obesity, diabetes), and (iii) socio-economic aspects, (e.g. inadequate health care access, stigma) may contribute to the development or progression of CKD although this has not been well studied.
There is growing recognition of the important role of social determinants of health (SDH) and its impact across a wide range of health indicators, settings, and populations (13,14). The World Health Organization (WHO) refers to SDH as conditions to which people are born, grow, work, live and age, linked to personal circumstances and systems (e.g. social, economic and political policies/heath care systems) that influences their daily lives (15-16). The new conceptual framework of syndemics provide an opportunity to study diseases and health conditions in populations that are deepened by the social, economic, environmental and political environment of a given population (17). The definition of a syndemic is 'the presence of two or more disease states (anchored around a core disease, in our case HIV) that adversely interact with each other, negatively affecting the mutual course of each disease trajectory, enhance vulnerability, and which are more harmful by experienced inequities' (18). This approach of a so-called 'syndemic lens' may be helpful in our study to identify the associations between genetic, biologic and social factors that contribute to the development of CKD and DM in people with hypertension, obesity, sub-clinical CKD and/or metabolic syndrome. This systemic approach can offer a new understanding of diseases that can improve public health and treat individual patients at the same time (19).
South London has a large (>200,000) population of African and Caribbean ancestry who are disproportionally affected by HIV and experience a higher burden of CKD, DM and other LTC, often with earlier onset compared to white populations. The investigators aim to study the demographic, clinical, social and genetic factors that associate with CKD, DM and multiple LTC in people with HIV. CKD and DM are key LTC that associate with hypertension, obesity and cardiovascular disease, resulting in or contribute to functional impairment, polypharmacy and impaired bio-psycho-social health outcomes.
The HIV clinics in South London provide a unique opportunity to access a diverse African and Caribbean population of working age in whom LTC can be studied. People with HIV from black African/Caribbean communities experience a high degree of social and economic deprivation, stigma, anxiety and depression which are considered important syndemic factors in the development of LTC. CKD and DM are common LTC, highly relevant to the black population, and relatively early events in the development of multiple and disabling LTC, thus identifying a population for targeted interventions that may reduce the rate of progression from a single to multiple LTC.
HIV infection, itself a LTC, can be effectively controlled with antiretroviral therapy, affording normal life expectancy and interrupting onward transmission. Routine care includes 6-12 monthly assessments for other LTCs, providing opportunities for recruitment of well characterised populations unselected for specific co-morbid conditions.
No studies to date in the UK have examined the contribution of biologic, clinical, social and genetic factors to the development of LTC in African/Caribbean populations with HIV to date. The team will generate detailed information on factors that associate with CKD, DM, CVD and multiple LTC as well as hypertension, sub-clinical CKD, obesity and insulin resistance, which often precede the development of CKD, DM and other LTC in this population. This study is likely to identify novel associations which can be confirmed and further explored in subsequent studies of HIV positive and general African/Caribbean populations. Stored biological samples will allow us to explore pathogenetic mechanisms in subsequent studies.
Key barriers to uptake of existing and novel interventions include low literacy levels, low perception of quality of life, lack of knowledge of LTCs, etc. The investigators will explore how best to overcome these barriers in focus groups and develop a culturally sensitive educational programme, aiming to reach individuals in communities that tend to poorly engage with health care and preventive programmes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Participants with CKD | – | –Recruitment is from a cohort of HIV positive individuals of African ancestry with Chronic Kidney Disease CKD defined as eGFR <60 mL/min/1.73m2, and/or albumin/creatinine ratio >30 mg/mmol or protein/creatinine ratio >50 mg/mmol Anticipated n=75 |
| Participants with diabetes | – | –Recruitment is from a cohort of HIV positive individuals of African ancestry with diabetes. Diabetes is defined as being on diabetic medications or HbA1c >48 mmol/mol. Anticipated n=75 |
| Participants with ischaemic heart disease/stroke | – | –Recruitment is from a cohort of HIV positive individuals of African ancestry with previous ischaemic heart disease or stroke Anticipated n=50 |
| No CKD/DM/CVD cohort | – | –Recruitment is from a cohort of HIV positive individuals of African ancestry who do not have CKD, diabetes or prior ischaemic heart disease/stroke. Anticipated n=200 |
Who may qualify
- Ages
- 18 months to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants will be sampled from an existing cohort from the GEN AFRICA (Genetics Markers of Kidney Disease Progression in People of African Heritage Study). 75 participants with CKD, 75 participants with diabetes, 50 participants with a history of ischaemic heart (IHD)disease/stroke and 200 participants without CKD, diabetes, IHD/stroke will be recruited.
Key inclusion criteria (2 listed)
- Having previously participated in the GEN-AFRICA study
- Aged 18-60 years
Key exclusion criteria (2 listed)
- Not having participated in the GEN-AFRICA study
- Aged >60 years
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
Obsity
Time frame: 24months
• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 1. Obesity
Hypertension
Time frame: 24months
• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 2. Hypertension
CKD
Time frame: 24months
• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 3. CKD
Metabolic Syndrome
Time frame: 24months
• To describe, in African/Caribbean adults with HIV, demographic, clinical, social, biologic, genetic factors associated with CVD, CKD, DM and multiple LTC and the major clinical risk factors for these: 4. Metabolic syndrome
Syndemic aspects and qualitative assessment of contextual factors associated with long term health conditions
Time frame: 24months
• To explore more subtle variations of contextual factors and experiences about the role of syndemic aspects and provide further insights that may have been missed by the "itemised" quantitative approach in outcome 1. (using validated tools such as DISCUS, HADS, EQ-5D-5L)
Educational
Time frame: 24months
• To develop and pilot an educational programme on an existing App to improve knowledge about CKD, DM and CVD in the local African/Caribbean community.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background1. GSTT Charity report: From one to many. Exploring people's progression to multiple longterm conditions in an urban environment. Guy's and St. Thomas' Charity, London, July 2018. p10. 2. Public Health England. HIV in the UK 2016 report.
- Background2. Public Health England. HIV in the UK 2016 report. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment _data/file/602942/HIV_in_the_UK_report.pdf
- Background3. Public Health England. Hepatitis B in London 2016 data. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment _data/file/801174/London_hepatitis_B_report_2016.pdf
- Background4. Public Health England. Positive Voices: The National Survey of People Living with HIV. Findings from the 2017 Survey. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/857922/PHE_positive_voices_report_2019.pdf
- Background: PubMed 26925525Saran R, Li Y, Robinson B, Abbott KC, Agodoa LY, Ayanian J, Bragg-Gresham J, Balkrishnan R, Chen JL, Cope E, Eggers PW, Gillen D, Gipson D, Hailpern SM, Hall YN, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Kalantar-Zadeh K, Kovesdy CP, Lu Y, Molnar MZ, Morgenstern H, Nallamothu B, Nguyen DV, O'Hare AM, Plattner B, Pisoni R, Port FK, Rao P, Rhee CM, Sakhuja A, Schaubel DE, Selewski DT, Shahinian V, Sim JJ, Song P, Streja E, Kurella Tamura M, Tentori F, White S, Woodside K, Hirth RA. US Renal Data System 2015 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2016 Mar;67(3 Suppl 1):Svii, S1-305. doi: 10.1053/j.ajkd.2015.12.014. No abstract available.
- Background: PubMed 21997394Kopp JB, Nelson GW, Sampath K, Johnson RC, Genovese G, An P, Friedman D, Briggs W, Dart R, Korbet S, Mokrzycki MH, Kimmel PL, Limou S, Ahuja TS, Berns JS, Fryc J, Simon EE, Smith MC, Trachtman H, Michel DM, Schelling JR, Vlahov D, Pollak M, Winkler CA. APOL1 genetic variants in focal segmental glomerulosclerosis and HIV-associated nephropathy. J Am Soc Nephrol. 2011 Nov;22(11):2129-37. doi: 10.1681/ASN.2011040388. Epub 2011 Oct 13.
- Background: PubMed 28720685Tin A, Scharpf R, Estrella MM, Yu B, Grove ML, Chang PP, Matsushita K, Kottgen A, Arking DE, Boerwinkle E, Le TH, Coresh J, Grams ME. The Loss of GSTM1 Associates with Kidney Failure and Heart Failure. J Am Soc Nephrol. 2017 Nov;28(11):3345-3352. doi: 10.1681/ASN.2017030228. Epub 2017 Jul 18.
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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.
Frank Post, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Diabetes Mellitus, run by King's College Hospital NHS Trust at 1 site 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 2 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Rachel Hung, MBChB (+447894346851, rachel.hung@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obsity (time frame: 24months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646408, which also lists 24 linked publications.
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 Nov 2020.