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Bariatric procedures and changes in incretines and gastric emptying

Bariatric procedures and changes in incretines and gastric emptying - BIG-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON40704
Enrollment
32
Registered
2014-10-08
Start date
2015-05-08
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric emptying Hormonal changes Transit time

Interventions

None listed

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: I. Patients who are approaching their two years follow-up after Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) and Laparoscopic Sleeve Gastrectomy (LSG) are eligble for inclusion. The patients will be arranged in one of the following four groups according to the Reinhold*s criteria:;- Good responders (EWL > 50%) two years after RYGB - Bad responders (EWL 50%) two years after LSG - Bad responders (EWL

Exclusion criteria

Exclusion criteria: - Binge-eating or associated eating disorder - Active drug or alcohol addiction - Gluten allergy - Inability to stop medication that affects the motility of the upper gastrointestinal tract (anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids) - Endocrine disease influencing gastric emptying (diabetes mellitus, hyper- or hypothyroidism). T2DM is not an exclusion criteria for patients receiving the DJBL because T2DM is a requirement for receiving the DJBL. Additionally, changes in GE rate will be determined 1 month after implantation. No significant changes in GE rate will be expected in this time period caused by their T2DM

Design outcomes

Primary

MeasureTime frame
Gastric emptying rate and incretin levels two years after LRYGB and LSG, and gastric emptying before and 1 month after DJBL implantation.

Secondary

MeasureTime frame
- Weight loss/ excess weight loss two years after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy - Quality of life two years after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy - Quality of life before and one month after implantation of the duodenal-jejunal bypass liner

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)