Metabolic Consequences of Gastrointestinal Surgery

NCT02836353 | Terminated

• 1 other identifier: A093993
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrectomy; Oesophagectomy; Dumping Syndrome; Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• Severity of hypoglycaemia during glucose tolerance test as measured by plasma glucose levels

  Glucose tolerance test immediately after drug intervention

Study Arms (3)

Observational only

NO INTERVENTION

Oral glucose tolerance test, neurocognitive questionnaire tasks only.

Somatostatin

EXPERIMENTAL

Oral glucose tolerance test after 100mcg Somatostatin

Drug: Somatostatin

Antibiotics

EXPERIMENTAL

Oral glucose tolerance test after treatment of small intestinal bacterial overgrowth

Drug: Rifaximin

Interventions

Somatostatin DRUG

Single dose of short acting Somatostatin (100mcg) pre Oral glucose tolerance test

Somatostatin

Rifaximin DRUG

1 week course of 400mg three times daily (TDS) pre Oral glucose tolerance test

Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have undergone previous oesophageal or gastric resection

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 29548882 RESULT

• 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 Transcriptomic and Peptidomic Profiling. Diabetes. 2019 May;68(5):1062-1072. doi: 10.2337/db18-0883. Epub 2019 Feb 7.

  PMID: 30733330 RESULT

• 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 Feb 5;26(6):1399-1408.e6. doi: 10.1016/j.celrep.2019.01.047.

  PMID: 30726726 RESULT

MeSH Terms

Conditions

Dumping Syndrome; Hypoglycemia

Interventions

Somatostatin; Rifaximin

Condition Hierarchy (Ancestors)

Postgastrectomy Syndromes; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Geoffrey P Roberts, MA BM BCh

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• Fiona M Gribble, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Associate

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 19, 2016
• Study Start: January 1, 2017
• Primary Completion: March 11, 2019
• Study Completion: March 11, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)