Gastric Emptying After Sleeve Gastrectomy

NCT06407193 | Recruiting DMC

• 1 other identifier: 2020-1690
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Sleeve gastrectomy (SG) increases gastrointestinal motility, which influences feelings of fullness and satiety. By understanding the differences in gastric emptying (GE) between patients with sufficient weight loss (Total weight loss \[TWL\] \> 35%) and insufficient weight loss (TWL \< 25%), better insight in the aetiology of weight loss after sleeve gastrectomy may be obtained. GE will be measured with scintigraphy and MRI.

Conditions

Gastric Emptying; Bariatric Surgery

Keywords

Gastric emptying; Gastric sleeve; MRI; Scintigraphy

Outcome Measures

Primary Outcomes (2)

• Gastric emptying compared between patients with poor and successful weight loss

  Gastric emptying (T1/2 \[min\] and retention \[%/min\])

  2-3 years

• Gastric emptying compared between measured with MRI and scintigraphy

  Gastric emptying (T1/2 \[min\] and retention \[%/min\])

  2-3 years

Secondary Outcomes (3)

• Sleeve characteristics compared between patients with successful and unsuccessful (poor) weight loss

  2-3 years

• to assess the association between gastric emptying rate and gastric sleeve characteristics in each group

  2-3 years

• to compare subjective ratings of gastric fullness and wellbeing between patients with successful and unsuccessful weight loss

  2-3 years

Study Arms (2)

Poor weight loss group

Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \< 25%

Other: MRI and scintigraphy

Successful weight loss group

Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with TWL \> 35%

Other: MRI and scintigraphy

Interventions

MRI and scintigraphy OTHER

Gastric emptying measured with MRI and scintigraphy

Poor weight loss group; Successful weight loss group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women after sleeve gastrectomy with either good or poor weight loss

You may qualify if:

• Women aged between 20 and 55 years who underwent sleeve gastrectomy as primary procedure with either TWL \< 25% or TWL \> 35%.
• Patients who had a follow-up period of 2-3 years after sleeve gastrectomy

You may not qualify if:

• Maximum BMI \>50 kg/m2
• Patients with a disease known to affect appetite, gastric emptying or gastrointestinal motility
• Patients who are unable to stop medications that affect gastric emptying and/or motility prior to measurements. It is depending on t1/2 for how long they need to stop medication
• Patients who started menopause
• Patients with gastrointestinal problems or, gastric or intestinal diseases
• Patients with a drug or alcohol addiction
• Patients who are unable to stop smoking for 24h
• Patients who are pregnant or lactating
• Patients who have an intolerance or allergy for one of the components of the test product
• Patients who have a contra-indication to MRI scanning

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Wageningen University and Research: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, Gelderland, 6815AD, Netherlands

RECRUITING

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Veerbeek

CONTACT

+31 880052115; tveerbeek@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 9, 2024
• Study Start: May 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

NL (1)