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

Completed

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT02302677

Run by

University of Nebraska

People needed

40

Starts

2015-01-01

Expected to finish

2017-09-20

Last updated by the study team

2023-09-06

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 19 years of age and ≤ 70 at the time of surgery
• Participant in the Surgical Weight Loss Program of the Bariatrics Center of UNMC
• SG approved to be completed at UNMC
• Primary bariatric surgery or prior band placement and removal over 2 years prior

You may not qualify if…

• Past medical history of small bowel resection or right colectomy
• History of cirrhosis
• Current or planned use of bile acid sequestrants
• Bariatric surgery being performed as a revisional procedure other than #4 as above. -

Where it is running

• Unversity of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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