NCT07666321

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2026

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

May 26, 2026

Last Update Submit

June 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • To investigate ethnic differences in glucose metabolism

    Dynamic glucose and insulin responses during Oral Glucose Tolerance Testing (OGTT) in mmol/L

    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.

    Baseline

Secondary Outcomes (2)

  • To investigate ethnic differences in adipokines

    Baseline

  • To investigate ethnic differences in inflammatory biomarkers

    Baseline

Study Arms (3)

Black African/Caribbean

Healthy males Black African/Caribbean

Other: Differences in Adipose tissue dysfunction and its contribution to T2DM - Black African/Caribbean

South Asian

Healthy males South Asian

Other: Differences in Adipose tissue dysfunction and its contribution to T2DM -South Asian

White European

Healthy males White European

Other: Differences in Adipose tissue dysfunction and its contribution to T2DM -White European

Interventions

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

Black African/Caribbean

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

South Asian

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

White European

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Male * Aged 18-65 years * Self-identify as one of the following ethnic groups: * Black African/Caribbean * South Asian * White European

You may qualify if:

  • 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
  • +1 more criteria

You may not qualify if:

  • 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
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Roehampton, School of Life and Health Sciences

London, UK, SW15 4JD, United Kingdom

Location

Adele Costabile

London, SW145JD, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • ADELE COSTABILE

    University of Roehampton

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Clinical Nutrition

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 24, 2026

Study Start

January 10, 2025

Primary Completion

May 12, 2026

Study Completion

May 15, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations