Gastrectomy Clinical Trial
— MaSOfficial title:
The Metabolic Consequences of Gastrointestinal Surgery
NCT number | NCT02836353 |
Other study ID # | A093993 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | March 11, 2019 |
Verified date | March 2019 |
Source | Cambridge University Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Surgery on the gastrointestinal (GI) tract results in profound changes to the metabolic profile. This is well described, including the rapid resolution of diabetes seen after bariatric surgery. The underlying pathophysiology, and incidence in lean patients undergoing surgery for cancer, is somewhat less described. The investigators plan to assess the symptomatic and glycaemic profile, as well as causative pathways, for metabolic symptoms in patients after surgery on the GI tract. The investigators will use glucose tolerance tests, physiological challenges with somatostatin analogues and antibiotics, and assess tissue transcriptomic changes.
Status | Terminated |
Enrollment | 81 |
Est. completion date | March 11, 2019 |
Est. primary completion date | March 11, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Have undergone previous oesophageal or gastric resection Exclusion Criteria: - Age <18 - Recent history of untreated anaemia - Donated blood in preceding 16 weeks - Lack capacity to read and retain information about study - Have a known allergy to interventional agent - Have received a course of antibiotics in preceding two months - Be on medication that interacts with intervention - Have a history of C. difficile colitis |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
Larraufie P, Roberts GP, McGavigan AK, Kay RG, Li J, Leiter A, Melvin A, Biggs EK, Ravn P, Davy K, Hornigold DC, Yeo GSH, Hardwick RH, Reimann F, Gribble FM. Important Role of the GLP-1 Axis for Glucose Homeostasis after Bariatric Surgery. Cell Rep. 2019 — View Citation
Roberts GP, Kay RG, Howard J, Hardwick RH, Reimann F, Gribble FM. Gastrectomy with Roux-en-Y reconstruction as a lean model of bariatric surgery. Surg Obes Relat Dis. 2018 May;14(5):562-568. doi: 10.1016/j.soard.2018.01.039. Epub 2018 Feb 3. — View Citation
Roberts GP, Larraufie P, Richards P, Kay RG, Galvin SG, Miedzybrodzka EL, Leiter A, Li HJ, Glass LL, Ma MKL, Lam B, Yeo GSH, Scharfmann R, Chiarugi D, Hardwick RH, Reimann F, Gribble FM. Comparison of Human and Murine Enteroendocrine Cells by Transcriptom — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Severity of hypoglycaemia during glucose tolerance test as measured by plasma glucose levels | Glucose tolerance test immediately after drug intervention |
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