Clinical Trial: Metabolic Consequences of Gastrointestinal Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Metabolic Consequences of Gastrointestinal Surgery

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.

Detailed Summary:

The role of the gut hormone axis in glucose control is of significant interest due to its proven translational impact in diabetes management. It is also significantly altered by gastric surgery, a procedure that can lead to deleterious symptoms (dumping syndrome) in lean, non-diabetic patients. The investigators will study a unique cohort of young, lean patients undergoing surgery for the prevention of gastric cancer, as well as patients undergoing surgery for gastric and oesophageal cancer, to further understand the regulation and pathophysiological role of the gut hormone axis. The prophylactic patient population will be recruited from the pool of patients with a genetic mutation conferring a high lifetime risk of gastric cancer (Hereditary Diffuse Gastric Cancer) for whom Addenbrooke's Hospital provides a national clinical service. The investigators aim to define the causative physiological pathways for dumping syndrome in this group and expand our body of knowledge of gut hormones and their role in glucose homeostasis and eating behaviour.

It has been suspected for some years that surgery has more profound physiological effects than simple anatomical rearrangement, however recent developments in bariatric surgery have brought this to the fore. The era of surgical treatment of peptic ulcer disease resulted in a large cohort of patients undergoing gastric surgery and suffering post-operative dumping symptoms. These include symptoms attributed to hypovolaemia immediately after a meal, followed by hypoglycaemia within a few hours. There was a significant hiatus in the study of dumping syndrome after the decline of surgery for ulcer disease in the 1980s. The major improvement in long-term survival after surgery for oesophageal and gastric cancer seen in the 21st Century, coupled with the identification of high risk familial cohorts who now undergo prophylactic gastrectomy,
Sponsor: Cambridge University Hospitals NHS Foundation Trust

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Cambridge University Hospitals NHS Foundation Trust

Dates:
Date Received: July 13, 2016
Date Started: January 2017
Date Completion:
Last Updated: January 11, 2017
Last Verified: January 2017