Metabolic Consequences of Gastrointestinal Surgery

What Was Tested

The trial (not phased) is built around Somatostatin.

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.

It had three arms (groups): Observational only (no intervention), Somatostatin (experimental) and Antibiotics (experimental).

Oral glucose tolerance test, neurocognitive questionnaire tasks only.

Oral glucose tolerance test after treatment of small intestinal bacterial overgrowth.

The registry classes the interventions as drug.

More on the Plan

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 their 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.

These include symptoms attributed to hypovolaemia immediately after a meal, followed by hypoglycaemia within a few hours.

Who Took Part

81 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Have undergone previous oesophageal or gastric resection.

The full record lists 1 inclusion and 8 exclusion criteria; among the exclusions: age \<18; recent history of untreated anaemia; donated blood in preceding 16 weeks.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Somatostatin group and the comparison group ran side by side rather than switching.

Everyone knew when Somatostatin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2017-01 with completion listed for 2019-03-11.

It ran at 1 site in United Kingdom.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Severity of hypoglycaemia during glucose tolerance test as measured by plasma glucose levels (time frame: Glucose tolerance test immediately after drug intervention).

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Somatostatin in 81 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page, all human trials.