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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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02781961
Enrollment
10
Registered
2016-05-25
Start date
2016-06-30
Completion date
2020-07-31
Last updated
2020-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Brief summary

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.

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.

Interventions

pCLE during gastroscopy

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
tissue morphology3 monthspCLE morphological characteristics of gastric and duodenal cells in obese individuals, before and after sleeve gastrectomy (when weight loss is achieved)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026