- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03864562
Gastric Emptying - Implications for the Pathogenesis of Type 2 Diabetes
Gastric Emptying in Non-diabetic Individuals With Black African/Caribbean Heritage - Implications for the Pathogenesis of Type 2 Diabetes
Study Overview
Status
Conditions
Detailed Description
Background It is recognized that there are differences between ethnic groups in the risk of developing type 2 diabetes (T2D), but the underlying pathophysiology remains poorly defined. For example, whilst insulin resistance, exacerbated by obesity, is common in Caucasian, Hispanic and South Asian populations, impairment in insulin secretion appears to be the primary defect in the pathogenesis of T2D in East Asians. Within the United Kingdom (UK), diabetes and its complications disproportionately affect ethnic minority groups, particularly those of black African-Caribbean (AfC) descent. Studies indicate that the rate of gastric emptying is a major determinant of postprandial glycemia and insulinemia in those with a White European (WE) background in both health and T2D, and although there is evidence that gastric emptying is influenced by ethnicity (which may contribute to the development of T2D), gastric emptying has, to our knowledge, not been evaluated in those of AfC heritage.
Aims The primary objective is to compare the gastric emptying rate in 2 UK ethnic groups. This will be done by conducting a descriptive, cross-sectional pilot study in 60 healthy participants. Secondary objectives are to determine any relationship between glycemia, insulinemia and incretin hormone secretion in these groups.
Experimental protocol Sixty volunteers; 30 of WE and 30 of black AfC heritage will be recruited. Following a successful medical screening visit, participants will be asked to record their dietary intake over 3 days before attending the laboratory for their study visit. On the day before the study visit they will be asked to avoid strenuous exercise, alcohol and caffeine intake and to eat their normal diet. On the study day, participants will arrive at the laboratory in the morning following an overnight fast. A cannula will be inserted into a vein in the top of the hand and the hand placed in a warming box for repeat arterialized-venous blood sampling over the study day. After baseline breath and blood samples have been taken, participants will then be given a drink containing 75g of glucose dissolved in 300ml water (standard oral glucose tolerance test), to which has been added 150mg of 13C labelled acetate, and asked to consume it within 5 minutes. The stable isotope label on the acetate allows us to assess gastric emptying by detecting the appearance of 13CO2 in breath. Blood samples (6ml) will be collected prior to the drink, with further samples being taken every 15min for the first 2hrs, then every 30min for the next hour, with a final sample taken at 4hrs. Blood will be analysed for glucose, insulin, C-peptide, Glucagon-like peptide 1 (GLP-1), glucagon, and Gastric inhibitory polypeptide (GIP). Following the drink, subjects will also be asked to complete satiety and GI symptom questionnaires every half hour throughout the study. At the end of the 4 hours, participants will be asked to complete a series of autonomic function tests, during which we will measure blood pressure and heart rate. These tests are 2mins of rhythmic breathing (5sec inhale: 5sec exhale) and postural change to standing from resting semi-supine. After this time, the cannula will be removed and the study is completed
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Notts
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Nottingham, Notts, United Kingdom, NG72UH
- David Greenfield Human Physiology Unit, University of Nottingham
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Black African or Caribbean
Healthy individuals of black African or Caribbean descent
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White European
Healthy individuals of white European descent
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric emptying rate
Time Frame: 4 hours
|
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)
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4 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attrition rate
Time Frame: 1 year
|
Number of participants completing the protocol as a proportion of those who were recruited to the study
|
1 year
|
Serum Insulin concentration
Time Frame: 4 hours
|
Serum Insulin response to the glucose drink, measured by serial blood sampling and later analysis using a radio-immuno assay (RIA)
|
4 hours
|
Whole blood glucose concentration
Time Frame: 4 hours
|
Blood glucose response to the glucose drink, measured by serial blood sampling and immediate analysis using the glucose oxidase method
|
4 hours
|
Plasma glucagon concentration
Time Frame: 4 hours
|
Plasma glucagon response to the glucose drink, measured by serial blood sampling and later analysis using an RIA
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4 hours
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Plasma GLP-1 concentration
Time Frame: 4 hours
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Plasma GLP-1 response to the glucose drink, measured by serial blood sampling and later analysis using an enzyme-linked immunosorbent assay (ELISA)
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4 hours
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Plasma GIP concentration
Time Frame: 4 hours
|
Plasma GIP response to the glucose drink, measured by serial blood sampling and later analysis using an enzyme-linked immunosorbent assay (ELISA)
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4 hours
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Serum C-peptide concentration
Time Frame: 4 hours
|
Serum C-peptide response to the glucose drink, measured by serial blood sampling and later analysis using an enzyme-linked immunosorbent assay (ELISA)
|
4 hours
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Recruitment rate
Time Frame: 1 year
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Number of people volunteering to take part in the study as a proportion of those expressing initial interest
|
1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Michael Horowitz, MD PhD, University of Adelaide
Publications and helpful links
General Publications
- 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.
- 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.
- Phillips WT. Gastric emptying in ethnic populations: possible relationship to development of diabetes and metabolic syndrome. Ethn Dis. 2006 Summer;16(3):682-92.
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
- 226-1901
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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