NCT03864562

Brief Summary

People of black African and Caribbean descent have a greater risk of developing type 2 diabetes than white Europeans. The aim of this study is to increase our knowledge of how the condition may arise, and what underlies this increased risk. Following a successful screening visit to confirm eligibility for the study, we will be investigating how quickly a glucose drink empties out of the stomach in 30 white Europeans and 30 people of black African or Caribbean descent. In addition, we will study the impact that gastric emptying rate has on blood glucose and satiety hormones released normally by the gut in response to eating. Blood and breath samples will be collected before and during an oral glucose tolerance test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3.6 years

First QC Date

March 4, 2019

Last Update Submit

March 26, 2026

Conditions

Diabetes Mellitus, Type 2

Keywords

gastric emptyingoral glucose tolerance testEthnicityDiabetes risk

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying rate

    Time for clearance of half of the glucose drink (measured via a stable isotope breath test and area under the incremental postprandial blood glucose response curve)

    4 hours

Secondary Outcomes (8)

  • Serum Insulin concentration

    4 hours

  • Whole blood glucose concentration

    4 hours

  • Plasma glucagon concentration

    4 hours

  • Plasma GLP-1 concentration

    4 hours

  • Plasma GIP concentration

    4 hours

  • +3 more secondary outcomes

Study Arms (2)

Black African or Caribbean

Healthy individuals of black African or Caribbean descent

White European

Healthy individuals of white European descent

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study cohort will be recruited from the general population of England who live within commuting distance from the study site, and will incorporate those from the counties of Nottinghamshire, Derbyshire and Leicestershire

You may qualify if:

  • White European or black African / Caribbean heritage
  • BMI \>18 kg/m2
  • Ability to give written informed consent
  • English speaking

You may not qualify if:

  • Any significant medical condition
  • Uncontrolled hypertension
  • Alcohol consumption \>14 units / week
  • Random blood Glucose concentration above 7.8mmol/l
  • Hemoglobin A1c (HbA1c) \>47mmol/mol (\>6.4%)
  • Use of regular medication, (oral contraceptive pill or antihypertensive medication are acceptable if use has been for \>6 months)
  • History of Irritable Bowel Syndrome, food intolerances or any gastrointestinal disorders
  • Previous bariatric surgery, or gastrointestinal surgery which may affect normal function (e.g. bowel resection)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

David Greenfield Human Physiology Unit, University of Nottingham

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (3)

  • Kodama K, Tojjar D, Yamada S, Toda K, Patel CJ, Butte AJ. Ethnic differences in the relationship between insulin sensitivity and insulin response: a systematic review and meta-analysis. Diabetes Care. 2013 Jun;36(6):1789-96. doi: 10.2337/dc12-1235.

    PMID: 23704681BACKGROUND

  • Horowitz M, Edelbroek MA, Wishart JM, Straathof JW. Relationship between oral glucose tolerance and gastric emptying in normal healthy subjects. Diabetologia. 1993 Sep;36(9):857-62. doi: 10.1007/BF00400362.

    PMID: 8405758BACKGROUND

  • Phillips WT. Gastric emptying in ethnic populations: possible relationship to development of diabetes and metabolic syndrome. Ethn Dis. 2006 Summer;16(3):682-92.

    PMID: 16937605BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael Horowitz, MD PhD

    University of Adelaide

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 6, 2019

Study Start

March 1, 2019

Primary Completion

September 30, 2022

Study Completion

March 31, 2023

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)