AdiposityADIT2DNCT07666321
Ethnic Differences in Adipose Tissue Dysfunction in the Development of Insulin Resistance and Type 2 Diabetes
An observational study of Adiposity, run by University of Roehampton at 2 sites in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Adiposity
- What is being tested?
- Differences in Adipose tissue dysfunction and its contribution to T2DM - Black African/Caribbean, Differences in Adipose tissue dysfunction and its contribution to T2DM -South Asian and Differences in Adipose tissue dysfunction and its contribution to T2DM -White European
- How many people
- 39 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 10 Jan 2025to 15 May 2026
- How long will I take part?
- 2 Months
- 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 65 years
- Men only
- Adult, Older adult
Study population: Healthy Male * Aged 18-65 years * Self-identify as one of the following ethnic groups: * Black African/Caribbean * South Asian * White European
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Roehampton, School of Life and Health Sciences
London, UK, SW15 4JD
Adele Costabile
London, SW145JD
About this study
Official title: 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.
Read more
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.
Read the 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
- Conditions
- Adiposity
- Being tested
- Differences in Adipose tissue dysfunction and its contribution to T2DM - Black African/Caribbean, Differences in Adipose tissue dysfunction and its contribution to T2DM -South Asian, Differences in Adipose tissue dysfunction and its contribution to T2DM -White European
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differences in Adipose tissue dysfunction and its contribution to T2DM - Black African/CaribbeanOther
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
Differences in Adipose tissue dysfunction and its contribution to T2DM -South AsianOther
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
Differences in Adipose tissue dysfunction and its contribution to T2DM -White EuropeanOther
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
| Study group | Role | What they receive |
|---|---|---|
| Black African/Caribbean | Healthy males Black African/Caribbean Receives: Other: Differences in Adipose tissue dysfunction and its contribution to T2DM - Black African/Caribbean | |
| South Asian | Healthy males South Asian Receives: Other: Differences in Adipose tissue dysfunction and its contribution to T2DM -South Asian | |
| White European | Healthy males White European Receives: Other: Differences in Adipose tissue dysfunction and its contribution to T2DM -White European |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate ethnic differences in glucose metabolism
Dynamic glucose and insulin responses during Oral Glucose Tolerance Testing (OGTT) in mmol/L
Measured: Baseline and after 2 hours and 10 minutes
To investigate ethnic differences adipose tissue dysfunction
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.
Measured: Baseline
Secondary outcomes (2)
To investigate ethnic differences in adipokines
Changes in Adipokine concentrations (adiponectin, leptin, resistin) expressed in mmol/L
Measured: Baseline
To investigate ethnic differences in inflammatory biomarkers
Changes in Inflammatory biomarkers (TNF-α, IL-6, IL-8, IL-10, IFN-γ, MCP-1, CRP) in ng/L
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start10 Jan 2025
- Primary completion12 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DR ADELE COSTABILE, University of Roehampton
- Investigators
- ADELE COSTABILE, Study director, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666321
- Sponsor's protocol ID
- LSC 24/399
- Acronym
- ADIT2D
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethnic Differences in the Role of Adipose Tissue Dysfunction in the Development of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07666321
- Acronym / sponsor ID
- ADIT2D / LSC 24/399
- Conditions
- Adiposity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 24 Jun 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Black African/Caribbean | – | Other: Differences in Adipose tissue dysfunction and its contribution to T2DM - Black African/CaribbeanHealthy males Black African/Caribbean |
| South Asian | – | Other: Differences in Adipose tissue dysfunction and its contribution to T2DM -South AsianHealthy males South Asian |
| White European | – | Other: Differences in Adipose tissue dysfunction and its contribution to T2DM -White EuropeanHealthy males White European |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Healthy Male * Aged 18-65 years * Self-identify as one of the following ethnic groups: * Black African/Caribbean * South Asian * White European
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (23 listed)
- 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:
- History of cardiovascular, hepatic, renal, endocrine, or metabolic disease that may interfere with study outcomes or participant safety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Differences in Adipose tissue dysfunction and its contribution to T2DM - Black African/Caribbeanto 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 | Other | Black African/Caribbean |
| Differences in Adipose tissue dysfunction and its contribution to T2DM -South Asianto 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 | Other | South Asian |
| Differences in Adipose tissue dysfunction and its contribution to T2DM -White Europeanto 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 | Other | White European |
Primary outcome
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
To investigate ethnic differences adipose tissue dysfunction
Time frame: Baseline
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.
2 secondary outcomes
To investigate ethnic differences in adipokines
Time frame: Baseline
To investigate ethnic differences in inflammatory biomarkers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
ADELE COSTABILE study director
University of Roehampton
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 Adiposity, run by University of Roehampton 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 16 inclusion and 23 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: finished, as of the sponsor's last update on 30 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate ethnic differences in glucose metabolism (time frame: Baseline and after 2 hours and 10 minutes). The study lists 2 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 Jun 2026; AzTrials last refreshed its copy on 2 Nov 2026.