Gastric Emptying in Non-diabetic Individuals With Black African/Caribbean Heritage - Implications for the Pathogenesis of Type 2 Diabetes
Study on Stomach Emptying and Diabetes Risk in Black African/Caribbean Individuals
Plain English Summary
Gastric Emptying - Implications for the Pathogenesis of Type 2 Diabetes is a Not Applicable clinical trial sponsored by University of Nottingham studying Diabetes Mellitus, Type 2. This study investigates how quickly food leaves the stomach in people of Black African/Caribbean heritage compared to White Europeans. It aims to understand why people of Black African/Caribbean descent have a higher risk of developing type 2 diabetes. Participants will drink a glucose solution and have blood and breath samples taken to measure how their body responds. This research is observational, meaning it observes health patterns without testing new treatments. The trial aims to enroll 56 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are of White European or Black African/Caribbean heritage and have a BMI over 18. You cannot join if you have any significant medical conditions, uncontrolled high blood pressure, or certain gastrointestinal issues. Individuals consuming more than 14 units of alcohol per week or with high blood sugar/HbA1c levels will not be eligible. You must be able to understand and provide written consent and speak English. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how quickly a glucose drink leaves the stomach, which can affect how blood sugar levels rise and how full you feel after eating. The specific primary outcome measures are: Gastric emptying rate (4 hours). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it seeks to uncover the reasons behind the higher risk of type 2 diabetes in people of Black African/Caribbean descent, addressing a gap in understanding this health di This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.
Investor Insight
This observational study provides foundational knowledge on diabetes risk factors, potentially informing future research and interventions in a large and growing market for diabetes management.
Is This Trial Right for Me?
Ask your doctor if this study relates to your personal risk factors for diabetes. Participation involves a screening visit, followed by a test where you drink a glucose solution and have samples taken over 4 hours. You will be asked about your diet and lifestyle as part of the study. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 56 participants
Primary Outcomes
- Gastric emptying rate (4 hours)
Secondary Outcomes
- 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)
Full Eligibility Criteria
Inclusion Criteria: * White European or black African / Caribbean heritage * BMI \>18 kg/m2 * Ability to give written informed consent * English speaking Exclusion Criteria: * 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)
Trial Locations
- David Greenfield Human Physiology Unit, University of Nottingham, Nottingham, Notts, United Kingdom
Frequently Asked Questions
What is clinical trial NCT03864562?
NCT03864562 is a Not Applicable OBSERVATIONAL study titled "Gastric Emptying - Implications for the Pathogenesis of Type 2 Diabetes." It is currently completed and is sponsored by University of Nottingham. The trial targets enrollment of 56 participants.
What conditions does NCT03864562 study?
This trial investigates treatments for Diabetes Mellitus, Type 2. The primary condition under study is Diabetes Mellitus, Type 2.
What does Not Applicable mean for NCT03864562?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT03864562?
This trial is currently "Completed." It started on 2019-03-01. The estimated completion date is 2023-03-31.
Who is sponsoring NCT03864562?
NCT03864562 is sponsored by University of Nottingham. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT03864562?
The trial aims to enroll 56 participants. The trial status is completed.
How is NCT03864562 designed?
This is a observational study.
What are the primary outcomes being measured in NCT03864562?
The primary outcome measures are: Gastric emptying rate (4 hours). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT03864562 being conducted?
This trial is being conducted at 1 site, including Nottingham, Notts (United Kingdom).
Where can I find official information about NCT03864562?
The official record for NCT03864562 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT03864562. This government database provides the most up-to-date and detailed information about the trial.
What is NCT03864562 testing in simple terms?
This study investigates how quickly food leaves the stomach in people of Black African/Caribbean heritage compared to White Europeans. It aims to understand why people of Black African/Caribbean descent have a higher risk of developing type 2 diabetes.
Why is this trial significant?
This trial is important because it seeks to uncover the reasons behind the higher risk of type 2 diabetes in people of Black African/Caribbean descent, addressing a gap in understanding this health di
What are the potential risks of participating in NCT03864562?
Potential risks include discomfort from blood draws or breath samples. Some participants might experience mild nausea or bloating after drinking the glucose solution. The study does not involve experimental treatments, so risks are related to the testing procedures themselves. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT03864562?
Ask your doctor if this study relates to your personal risk factors for diabetes. Participation involves a screening visit, followed by a test where you drink a glucose solution and have samples taken over 4 hours. You will be asked about your diet and lifestyle as part of the study. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT03864562 signal from an investment perspective?
This observational study provides foundational knowledge on diabetes risk factors, potentially informing future research and interventions in a large and growing market for diabetes management. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will drink a glucose solution and have blood and breath samples taken to measure how their body responds. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Diabetes Mellitus, Type 2 Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.