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Trial record 6 of 7 for:    "Postgastrectomy Syndrome" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

Metabolic Consequences of Gastrointestinal Surgery (MaS)

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ClinicalTrials.gov Identifier: NCT02836353
Recruitment Status : Terminated (Reached scientific goals, further recruitment would not further advance the findings of study.)
First Posted : July 19, 2016
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Geoffrey Roberts, Cambridge University Hospitals NHS Foundation Trust

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastrectomy Oesophagectomy Dumping Syndrome Hypoglycaemia Drug: Somatostatin Drug: Rifaximin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Metabolic Consequences of Gastrointestinal Surgery
Actual Study Start Date : January 2017
Actual Primary Completion Date : March 11, 2019
Actual Study Completion Date : March 11, 2019

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Arm Intervention/treatment
No Intervention: Observational only
Oral glucose tolerance test, neurocognitive questionnaire tasks only.
Experimental: Somatostatin
Oral glucose tolerance test after 100mcg Somatostatin
Drug: Somatostatin
Single dose of short acting Somatostatin (100mcg) pre Oral glucose tolerance test

Experimental: Antibiotics
Oral glucose tolerance test after treatment of small intestinal bacterial overgrowth
Drug: Rifaximin
1 week course of 400mg three times daily (TDS) pre Oral glucose tolerance test




Primary Outcome Measures :
  1. Severity of hypoglycaemia during glucose tolerance test as measured by plasma glucose levels [ Time Frame: Glucose tolerance test immediately after drug intervention ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836353


Locations
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United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Geoffrey P Roberts, MA BM BCh University of Cambridge
Principal Investigator: Fiona M Gribble, PhD University of Cambridge

Publications of Results:
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Responsible Party: Geoffrey Roberts, Clinical Research Associate, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02836353     History of Changes
Other Study ID Numbers: A093993
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Postgastrectomy Syndromes
Hormones, Hormone Substitutes, and Hormone Antagonists
Dumping Syndrome
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Postoperative Complications
Pathologic Processes
Rifaximin
Somatostatin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Hormones
Physiological Effects of Drugs