- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07666321
Ethnic Differences in Adipose Tissue Dysfunction in the Development of Insulin Resistance and Type 2 Diabetes (ADIT2D)
Ethnic Differences in the Role of Adipose Tissue Dysfunction in the Development of Type 2 Diabetes
This pilot study investigates the relationship between type 2 diabetes (T2D) and adipose tissue dysfunction across different ethnic groups. Adipose tissue dysfunction is characterised by abnormal fat distribution, including increased visceral, hepatic, and pancreatic fat, elevated inflammatory biomarkers, and impaired metabolic function.
T2D is a chronic metabolic disease characterised by insulin resistance and disrupted glucose regulation. In the UK, its prevalence is significantly higher among South Asian and Black African/Caribbean populations than among White Europeans. Differences in adipose tissue distribution, particularly increased visceral fat accumulation, are thought to contribute to this disparity. Adipose tissue dysfunction, including chronic inflammation and altered adipokine secretion, is also associated with the development and progression of T2D.
Previous studies have identified ethnic differences in body fat distribution and metabolic risk. Genetic factors influencing adipose tissue function may partly explain variations in fat storage and susceptibility to T2D across populations. However, the specific contribution of adipose tissue dysfunction to ethnic differences in T2D risk remains unclear.
Evidence suggests that South Asians tend to have higher levels of liver and ectopic fat and a reduced capacity for safe subcutaneous fat storage, leading to fat accumulation in metabolically harmful sites. These characteristics are associated with increased insulin resistance and T2D risk. In contrast, Black populations often exhibit lower levels of visceral fat but still experience a high prevalence of T2D, indicating that factors beyond fat quantity may contribute to disease risk.
Despite extensive research on ethnic disparities in metabolic health, few studies have directly compared markers of adipose tissue dysfunction across South Asian, Black African/Caribbean, and White European populations within a single study. This study aims to address this gap and improve understanding of the mechanisms linking adipose tissue dysfunction, insulin resistance, and T2D. The findings may help inform more targeted prevention and treatment strategies for ethnically diverse populations in the UK.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
References:
- Amati, F., Pennant, M., Azuma, K., Dubé, J.J., Toledo, F.G.S., Rossi, A.P., Kelley, D.E. and Goodpaster, B.H. (2012). Lower Thigh Subcutaneous and Higher Visceral Abdominal Adipose Tissue Content Both Contribute to Insulin Resistance. Obesity, 20(5), pp.1115-1117. doi:https://doi.org/10.1038/oby.2011.401.
- Goff, L M. "Ethnicity and Type 2 diabetes in the UK." Diabetic medicine : a journal of the British Diabetic Association vol. 36,8 (2019): 927-938. doi:10.1111/dme.13895
- Iliodromiti, S. et al. (2023) "Liver, visceral and subcutaneous fat in men and women of South Asian and White European descent: A systematic review and meta-analysis of new and published data," Diabetologia, 66(1), pp. 44-56. Available at: https://doi.org/10.1007/s00125-022-05803-5.
- Lauro, D. et al. (1998) 'Impaired glucose tolerance in mice with a targeted impairment of insulin action in muscle and adipose tissue', Nature Genetics, 20(3), p. 294. doi:10.1038/3112.
- Unamuno, X., Gómez-Ambrosi, J., Rodríguez, A., Becerril, S., Frühbeck, G. and Catalán, V. (2018). Adipokine dysregulation and adipose tissue inflammation in human obesity. European Journal of Clinical Investigation, 48(9), p.e12997. doi:https://doi.org/10.1111/eci.12997.
- Yaghootkar, H et al. "Ethnic differences in adiposity and diabetes risk - insights from genetic studies." Journal of internal medicine vol. 288,3 (2020): 271-283. doi:10.1111/joim.13082
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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London, United Kingdom, SW145JD
- Adele Costabile
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UK
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London, UK, United Kingdom, SW15 4JD
- University of Roehampton, School of Life and Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Healthy Male
- Aged 18-65 years
Self-identify as one of the following ethnic groups:
- Black African/Caribbean
- South Asian
- White European
Description
Inclusion Criteria:
- Male
- Aged 18-65 years
- Self-identify as one of the following ethnic groups:
Black African/Caribbean South Asian White European
- Self-reported ancestry from the same ethnic background for at least three generations
- Body Mass Index (BMI) ≥25 kg/m² and ≤40 kg/m²
- Overweight or obese but otherwise generally healthy
- Generally healthy, with no serious long-term medical conditions or taking medications that may alter body fat distribution
- Residing in the United Kingdom
- Able to understand written and spoken English
- Able and willing to provide written informed consent
Willing and able to comply with all study procedures, including:
- Screening assessments
- Oral Glucose Tolerance Test (OGTT)
- Blood sampling
- Magnetic Resonance Imaging (MRI)
Exclusion Criteria:
- Previous diagnosis of type 1 diabetes mellitus or type 2 diabetes mellitus
- HbA1c values within the diabetic range at screening
- Body Mass Index (BMI) <25 kg/m²
Presence of chronic medical conditions known to affect:
- glucose metabolism
- insulin sensitivity
- adipose tissue distribution
- inflammatory or metabolic status
- History of cardiovascular, hepatic, renal, endocrine, or metabolic disease that may interfere with study outcomes or participant safety
Current use of medications known to influence:
- glucose metabolism
- insulin sensitivity
- lipid metabolism
- body composition
- Current use of corticosteroids or other medications affecting metabolic function
- history of substance or alcohol misuse
Contraindications to MRI, including:
- metallic implants
- pacemakers
- severe claustrophobia
- Inability to undergo venepuncture or cannulation procedures safely
- Participation in another clinical or interventional research study within the previous 3 months
- Inability or unwillingness to comply with study procedures or provide informed consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Black African/Caribbean
Healthy males Black African/Caribbean
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to investigate ethnic differences in adipose tissue dysfunction and its contribution to the development of type 2 diabetes mellitus in overweight and obese men from different ethnic backgrounds
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South Asian
Healthy males South Asian
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to investigate ethnic differences in adipose tissue dysfunction and its contribution to the development of type 2 diabetes mellitus in overweight and obese men from different ethnic backgrounds
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White European
Healthy males White European
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to investigate ethnic differences in adipose tissue dysfunction and its contribution to the development of type 2 diabetes mellitus in overweight and obese men from different ethnic backgrounds
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To investigate ethnic differences in glucose metabolism
Time Frame: Baseline and after 2 hours and 10 minutes
|
Dynamic glucose and insulin responses during Oral Glucose Tolerance Testing (OGTT) in mmol/L
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Baseline and after 2 hours and 10 minutes
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To investigate ethnic differences adipose tissue dysfunction
Time Frame: Baseline
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Regional adipose tissue distribution assessed by MRI.
MRI scans will be used to measure the volume and distribution of adipose tissue in specific regions, including visceral adipose tissue (fat surrounding internal organs), subcutaneous adipose tissue (fat beneath the skin), and ectopic fat accumulation in organs such as the liver and pancreas.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To investigate ethnic differences in adipokines
Time Frame: Baseline
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Changes in Adipokine concentrations (adiponectin, leptin, resistin) expressed in mmol/L
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Baseline
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To investigate ethnic differences in inflammatory biomarkers
Time Frame: Baseline
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Changes in Inflammatory biomarkers (TNF-α, IL-6, IL-8, IL-10, IFN-γ, MCP-1, CRP) in ng/L
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: ADELE COSTABILE, University of Roehampton
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSC 24/399
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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