NCT03860623

Brief Summary

Obesity is a complicated condition that is poorly understood. The aim of this study is to increase our knowledge of how the condition may arise, and what makes obese people remain obese. We will be investigating 12 people who are overweight and comparing them to 12 people who are lean, to look at how quickly food empties out of the stomach (gastric emptying) and travels through the gut, what the blood flow to the gut is, and also to examine the hormones which are involved in determining how full people feel after eating. In order to do this, we will be using a magnetic resonance imaging (MRI) scanner, and performing blood tests. The rate of gastric emptying may have an impact on satiety (how full one feels) and has been implied in the development of obesity. This effect has been shown to impact on subsequent meal intake to a greater degree in overweight subjects, and may be due to a difference in gastric emptying of food in overweight individuals, or to hormones such as ghrelin, glucagon-like peptide 1, and Peptide YY.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

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

November 7, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

3.2 years

First QC Date

February 25, 2019

Last Update Submit

November 26, 2025

Conditions

Keywords

satietygut blood flowgastric emptyingobesityincretin hormones

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying rate

    time taken for a standard meal to empty from the stomach, assessed by serial volume measurements of the stomach using magnetic resonance imaging

    240 minutes after feeding

Secondary Outcomes (23)

  • Stomach volume in the fasted state

    baseline

  • Superior mesenteric artery (SMA) blood flow in the fasted state

    baseline

  • superior mesenteric artery (SMA) blood flow response to feeding

    240 minutes after feeding

  • Fasting blood glucose concentration

    before feeding

  • Blood glucose response to feeding

    300 minutes after feeding

  • +18 more secondary outcomes

Study Arms (2)

Overweight

Otherwise healthy overweight and obese men (BMI 30-40kg/m2) aged 18 to 60 years Group will consume a standard meal (Feeding) and measurements will be made before (baseline) and for 300 minutes after eating

Normal Weight

Healthy normal weight men (BMI 18-25kg/m2, but including those with BMI up to 28kg/m2 if waist circumference \<96cm) aged 18 to 60 years Group will consume a standard meal (Feeding) and measurements will be made before (baseline) and for 300 minutes after eating

Eligibility Criteria

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

Recruitment will be from the male population residing within 20 miles of the research site. This will include those from Nottinghamshire, Leicestershire and Derbyshire, UK

You may qualify if:

  • BMI 30-40 kg/m2
  • BMI 18-25 kg/m2; those with BMI up to 28kg/m2 will be included if waist circumference is \<96cm.
  • Males
  • Aged 18-60yrs

You may not qualify if:

  • Acute illness in the preceding 6 weeks
  • Taking regular medication
  • History of deep vein thrombosis or clotting disorders
  • Hypertension
  • Diabetes
  • Any clinically significant findings at screening
  • History of substance abuse
  • Demonstrating factors precluding safe MRI
  • History of gastrointestinal motility disorders (e.g. gastroesophageal reflux disease -irritable bowel syndrome, gastroparesis, sphincter of Oddi dysfunction, etc.)
  • Previous thoracic or abdominal surgery.
  • Those who report having ≤3 bowel movements/week or \>2/day.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queens Medical Centre

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (6)

  • Fu XY, Li Z, Zhang N, Yu HT, Wang SR, Liu JR. Effects of gastrointestinal motility on obesity. Nutr Metab (Lond). 2014 Jan 7;11(1):3. doi: 10.1186/1743-7075-11-3.

    PMID: 24398016BACKGROUND
  • Vatner SF, Franklin D, Van Citters RL. Mesenteric vasoactivity associated with eating and digestion in the conscious dog. Am J Physiol. 1970 Jul;219(1):170-4. doi: 10.1152/ajplegacy.1970.219.1.170. No abstract available.

    PMID: 4393203BACKGROUND
  • Alyami J, Spiller RC, Marciani L. Magnetic resonance imaging to evaluate gastrointestinal function. Neurogastroenterol Motil. 2015 Dec;27(12):1687-92. doi: 10.1111/nmo.12726.

    PMID: 26598049BACKGROUND
  • Hoad CL, Parker H, Hudders N, Costigan C, Cox EF, Perkins AC, Blackshaw PE, Marciani L, Spiller RC, Fox MR, Gowland PA. Measurement of gastric meal and secretion volumes using magnetic resonance imaging. Phys Med Biol. 2015 Feb 7;60(3):1367-83. doi: 10.1088/0031-9155/60/3/1367. Epub 2015 Jan 16.

    PMID: 25592405BACKGROUND
  • Totman JJ, Marciani L, Foley S, Campbell E, Hoad CL, Macdonald IA, Spiller RC, Gowland PA. Characterization of the time course of the superior mesenteric, abdominal aorta, internal carotid and vertebral arteries blood flow response to the oral glucose challenge test using magnetic resonance imaging. Physiol Meas. 2009 Oct;30(10):1117-36. doi: 10.1088/0967-3334/30/10/011. Epub 2009 Sep 16.

    PMID: 19759401BACKGROUND
  • Simpson EJ, Althubeati S, Cordon S, Hoad C, Bush D, Eldeghaidy S, Gowland PA, Macdonald IA, Lobo DN. The effect of oral feeding on gastrointestinal function, motility and appetite-regulating hormones, insulin, glucose and satiety in normal weight individuals and those with obesity. Clin Nutr. 2025 Sep;52:62-71. doi: 10.1016/j.clnu.2025.07.008. Epub 2025 Jul 8.

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dileep Lobo, MD, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

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

February 25, 2019

First Posted

March 4, 2019

Study Start

November 7, 2018

Primary Completion

December 31, 2021

Study Completion

October 28, 2022

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations