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NCT Number: NCT02589587

Enteroendocrine Cells Before and After Sleeve Gastrectomy

Morbidly obese patients exhibit impaired secretion of satiation hormones which may contribute to the development of obesity. Bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. The investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, CH-4031, Switzerland

About this study

Morbidly obese patients exhibit impaired secretion of satiation hormones cholecystokinin (CCK), glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), which may contribute to the development of obesity. Bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. A better understanding of mechanisms involved will assist in development of non-invasive therapeutic strategies. The investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls. Gastric and intestinal mucosa will be collected by endoscopy from morbidly obese subjects before and 3 months after sleeve gastrectomy. In Addition, lean controls will be examined. Expression of various gut peptides will be assessed by immunohistochemistry and quantitative polymerase chain reaction (PCR).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Morbidly obese patients scheduled for sleeve gastrectomy

  • BMI > 35 kg/m2
  • Age: > 18-65 years Lean, healthy controls
  • BMI > 18 and < 28kg/m2
  • Age: >18-40 years

Exclusion criteria

  • Bleeding diathesis
  • Previous surgery on the gastrointestinal tract (appendectomy acceptable)

Treatment and study plan

Sleeve gastrectomy

Procedure

Sleeve gastrectomy is an established form of bariatric (weight reducing) surgery, where the greater curvature of the stomach is removed.

No intervention

Other

lean control group

Primary outcomes

  1. Quantification of the enteroendocrine cell population

    Time frame: within 3 months after surgery

    Expression of enteroendocrine cell population possessing chromogranin A, ghrelin, CCK, PYY, GLP-1 and GLP-2 by immunohistochemistry and quantitative PCR.

Secondary outcomes

  1. Determination of tissue morphology (crypt depth, villus height)

    Time frame: within 3 months after surgery

    Morphometric analysis

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Enteroendocrine Cells in Lean Controls and Healthy Subjects Before and After Sleeve Gastrectomy

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Oct 28, 2015
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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