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Gastric Emptying - Implications for the Pathogenesis of Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03864562
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
University of Adelaide
Information provided by (Responsible Party):
Elizabeth Simpson, University of Nottingham

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.

Condition or disease
Diabetes Mellitus, Type 2

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


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Gastric Emptying in Non-diabetic Individuals With Black African/Caribbean Heritage - Implications for the Pathogenesis of Type 2 Diabetes
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Black African or Caribbean
Healthy individuals of black African or Caribbean descent
White European
Healthy individuals of white European descent



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. Plasma GLP-1 concentration [ Time Frame: 4 hours ]
    Plasma GLP-1 response to the glucose drink, measured by serial blood sampling and later analysis using an enzyme-linked immunosorbent assay (ELISA)

  5. 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)

  6. 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)

  7. Attrition rate [ Time Frame: 1 year ]
    Number of participants completing the protocol as a proportion of those who were recruited to the study

  8. Recruitment rate [ Time Frame: 1 year ]
    Number of people volunteering to take part in the study as a proportion of those expressing initial interest



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03864562


Contacts
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Contact: Liz Simpson, PhD +44 (0)7864982800 liz.simpson@nottingham.ac.uk
Contact: Melanie Marshall, BSc +44 (0)115 951 5151 ext 19105 Melanie.Marshall@nottingham.ac.uk

Locations
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United Kingdom
David Greenfield Human Physiology Unit, University of Nottingham Recruiting
Nottingham, Notts, United Kingdom, NG72UH
Contact: Sara Brown    +44(0)115 8234034    sara.brown@nottingham.ac.uk   
Contact: Melanie Marshall, BSc    +44 (0) 115 951 5151 ext 19105    Melanie.Marshall@nottingham.ac.uk   
Principal Investigator: Ian A Macdonald, PhD         
Sub-Investigator: Liz J Simpson, PhD         
Sponsors and Collaborators
University of Nottingham
University of Adelaide
Investigators
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Study Director: Michael Horowitz, MD PhD University of Adelaide

Publications:
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Responsible Party: Elizabeth Simpson, Senior Research Fellow, University of Nottingham
ClinicalTrials.gov Identifier: NCT03864562     History of Changes
Other Study ID Numbers: 226-1901
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elizabeth Simpson, University of Nottingham:
gastric emptying
oral glucose tolerance test
Ethnicity
Diabetes risk

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases