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NCT02302677 · ClinicalTrials.gov registry record
The Effect of Sleeve Gastrectomy on Post-prandial Serum Bile Acids
A clinical trial, sponsored by University of Nebraska.
- Completed
- Registry status
- 40
- Enrollment target
NCT02302677: Completed study, sponsored by University of Nebraska.
NCT02302677 is a clinical trial that has completed, run by University of Nebraska. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02302677 has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Serum bile acids will be measured prior to surgery and at 1, 3 and 12 months post-surgery. The level of this compound will be compared to weight loss and satiety.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-01-01 |
| Est. Completion | 2017-09-20 |
What the finished NCT02302677 record still lists
NCT02302677 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02302677 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02302677 about?
NCT02302677 is a clinical study titled "The Effect of Sleeve Gastrectomy on Post-prandial Serum Bile Acids". 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 ste...
What is the current status of trial NCT02302677?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2015-01-01. Estimated completion is 2017-09-20.
Who is sponsoring clinical trial NCT02302677?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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