Determinants of Cardiovascular Disease, Kidney Disease and Diabetes

NCT04646408 | Unknown

• 1 other identifier: KingCKD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Chronic Kidney Diseases

Keywords

chronic kidney disease; cardiovascular disease; HIV; syndemic; diabetes

Outcome Measures

Primary Outcomes (6)

• 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: 1\. Obesity

  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

  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

  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

  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)

  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.

  24months

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Months - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Having previously participated in the GEN-AFRICA study
• Aged 18-60 years

You may not qualify if:

• Not having participated in the GEN-AFRICA study
• Aged \>60 years

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College London

London, Apartment G02, Cordage House, SE59RS, United Kingdom

RECRUITING

Related Publications (24)

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• 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

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• 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

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• 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

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  PMID: 22832513 BACKGROUND

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  PMID: 20647424 BACKGROUND

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Biospecimen

Retention: SAMPLES WITHOUT DNA

* CKD: creatinine, albuminuria \[ACR\], proteinuria \[PCR\] * Diabetes: glucose and HbA1c * Metabolic: full lipid profile incl. HDL-cholesterol, triglycerides\] * If no recent measures available: HIV RNA, Haemoglobin, Platelets, Liver enzymes \[AST, ALT and GGT\] * Inflammatory biomarkers: C-reactive protein (CRP) * Samples for future biomarkers e.g. C-peptide and inflammatory markers

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rachel Hung, MBChB

CONTACT

+447894346851; rachel.hung@kcl.ac.uk

Frank Post, PhD

CONTACT

frank.post@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: November 30, 2020
• Study Start: October 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-08

Locations

GB (1)