NCT02302677: BAS

The Effect of Sleeve Gastrectomy on Post-prandial Serum Bile Acids

Completed Last updated 6 September 2023

What this trial tests

trial in Obesity in 40 participants. Completed in 20 September 2017.

Timeline

1 January 2015

Primary endpoint
15 August 2016

20 September 2017

Quick facts

Lead sponsor	University of Nebraska
Status	Completed
Study type	OBSERVATIONAL
Enrollment	40
Start date	1 January 2015
Primary completion	15 August 2016
Estimated completion	20 September 2017
Sites	1 location across United States

Conditions studied

• Obesity — all drugs for Obesity →

Sponsor

University of Nebraska

Who can join

Adults 19 to 70, any sex, with Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective study of meal-induced bile acid physiology before and after sleeve gastrectomy (SG) surgery. Weight loss and metabolic improvement associated with weight loss surgery cannot be entirely attributed to restriction in stomach size and food intake. Bile acids (BAs), amphipathic steroids that have a role in lipid uptake and metabolism in the gastrointestinal tract, are involved in post-prandial glucose homeostasis and energy expenditure \& are a potential intermediary in weight loss following bariatric surgery. It is unknown if SG increases post-prandial BAs in humans and if an increase in BA signaling impacts weight loss and co-morbidity resolution after surgery. The investigators hypothesis is that SG will increase the post-prandial serum and urine BAs and that the change in the BA profile is a mechanism for restriction-independent weight-loss following SG. SG patients will undergo a meal challenge pre-operatively, and at 1, 3, and 12 months post-operatively, with measurement of post-prandial serum and urine BAs and downstream hormones, glucagon-like peptide 1 (GLP-1) and fibroblast growth factor 19 (FGF19), and a scoring of satiety before and after the meal challenge using a Visual Analog Scale. Serum insulin, glucose, and C4 levels will also be measured to assess metabolic changes associated with SG. Serum and urine BA levels will be compared to post-operative excess weight loss at 12 months. Before and after each meal challenge, patients will be asked to score satiety, and this will be correlated to weight loss, bile acids, GLP-1, and FGF19.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Increased glycine-amidated hyocholic acid correlates to improved early weight loss after sleeve gastrectomy.
   Kindel TL, Krause C, Helm MC, McBride CL, et al · · 2018 · cited 14× · PMID 28779240 · DOI 10.1007/s00464-017-5747-y