Bariatric Surgery Clinical Trial
— BIPOfficial title:
Bariatric Procedures and Changes in Gut Hormone and Gastric Passage
| NCT number | NCT04972357 |
| Other study ID # | 2018-1172 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 1, 2018 |
| Est. completion date | July 16, 2019 |
| Verified date | July 2021 |
| Source | Rijnstate Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Gastric emptying measured with scintigraphy in patients after standard Roux-en-Y Gastric Bypass (S-RYGB), Banded-RYGB (B-RYGB) or Extended pouch-RYGB (E-RYGB).
| Status | Completed |
| Enrollment | 15 |
| Est. completion date | July 16, 2019 |
| Est. primary completion date | July 16, 2019 |
| Accepts healthy volunteers | |
| Gender | Female |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: Female patients who underwent S-RYGB, B-RYGB or E-RYGB as a primary bariatric surgery. Exclusion Criteria: (1) had a disease known to affect appetite, gastric emptying or gastrointestinal motility (e.g., diabetes mellitus or hyper-/hypothyroidism); (2) were unable to stop medications that affect gastric emptying and/or motility three days prior to measurements (e.g., anti-cholinergic drugs, prokinetics, theophylline, calcium blocking agents, opioids); (3) started menopause; (4) were pregnant or lactating; (5) had a drug or alcohol addiction; (6) were unable to stop smoking for 24 hours. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Rijnstate Hospital | Arnhem |
| Lead Sponsor | Collaborator |
|---|---|
| Rijnstate Hospital |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Gastric emptying rate | cross-sectional study. Measured once over a period of 45-60 minutes |
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