Identification of In-vivo Probe Based Confocal Laser Endomicroscopy Cellular Characteristics in Obese Women

Identification of In-vivo Probe Based Confocal Laser Endomicroscopy (pCLE) Gastric & Duodenal Cellular Characteristics in Obese Women Before & After Weight Reduction

Previous studies have shown that histological changes in the gastric mucosa between obese and non-obese individuals do exist. Understanding these histological differences (between obese and non-obese individuals) might elucidate obesity pathophysiology.

However, the data is scarce and even contradictory. Even less is known about the histological characteristics of the duodenal mucosa in obesity and lean states, but several studies already performed hint for some differences. These differences might influence gut hormones composition and function and play a crucial role in the development of obesity and metabolic syndrome. To our best knowledge, in-vivo, human, real-time cellular level comparison of gastric and duodenal mucosa has never been done. This can be now accomplished with pCLE.

pCLE, is composed from a miniature microscope assembled in the tip of an optical fiber. This optic fiber is then inserted through the working channel of a standard endoscope, bringing the microscope at the tip of the fiber to close proximity with the tissue. The system applies a blue-light laser that after staining with fluorescein (IV 2.5 ml, 10% fluorescein, once) provides a cellular-level, in-vivo, real time images: the concept of so called "optical biopsies". The system has been used as an auxiliary tool in GI-endoscopy in recent years. This technology has been shown to be useful in identifying objective histological features and even intramucosal bacteria in different tissues.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: cellvizio

Detailed Description

Previous studies have shown that histological changes in the gastric mucosa between obese and non-obese individuals do exist, mainly in the cells producing the hormone ghrelin, but also in other gut hormones. Understanding these histological differences (between obese and non-obese individuals) might elucidate obesity pathophysiology, however, the data is scarce and even contradictory. Even less is known about the histological characteristics of the duodenal mucosa in obesity and lean states, but several studies already performed hint for some differences.. In conclusion, the investigators assume that obese and non-obese individuals may have gastric and/or duodenal histological differences. These differences might influence gut hormones composition and function and play a crucial role in the development of obesity and metabolic syndrome. To our best knowledge, in-vivo, human, real-time cellular level comparison of gastric and duodenal mucosa as well as differences in the microbiome of the stomach and duodenum between obese and non-obese individuals has never been done. This can be now accomplished with pCLE.

pCLE, is composed from a miniature microscope assembled in the tip of an optical fiber. This optic fiber is then inserted through the working channel of a standard endoscope, bringing the microscope at the tip of the fiber to close proximity with the tissue. The system applies a blue-light laser that after staining with fluorescein (IV 2.5 ml, 10% fluorescein, once) provides a cellular-level, in-vivo, real time images: the concept of so called "optical biopsies". The system has been used as an auxiliary tool in GI-endoscopy in recent years. This technology has been shown to be useful in identifying objective histological features and even intramucosal bacteria in different tissues.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Israel
  • Tel HaShomer, Israel, 52621
    • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Obese patients, referred for bariatric sleeve gastrectomy.

Description

Inclusion Criteria:

• >18 years
• BMI>= 35 with MS or
• BMI>=40 without MS

Exclusion Criteria:

• HIV infection
• Active Helicobacter Pylori infection
• CELIAC disease
• Autoimmune gastritis as defined by B12 deficiency and the presence of anti-intrinsic factor/ anti-parietal Ab's
• Concomitant disease with potential upper GI involvement
• Pregnancy
• Participation in another clinical trial
• Declined to sign an informed consent

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue morphology	pCLE morphological characteristics of gastric and duodenal cells in obese individuals, before and after sleeve gastrectomy (when weight loss is achieved)	3 months

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ACTUAL): July 1, 2020
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: May 17, 2016
• First Submitted That Met QC Criteria: May 20, 2016
• First Posted (ESTIMATE): May 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: SMC-15-2353

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO