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

This study is currently recruiting participants.
Verified October 2017 by Dr. Ofir Harnoy MD, Sheba Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781961
First Posted: May 25, 2016
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Ofir Harnoy MD, Sheba Medical Center
  Purpose

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.


Condition Intervention
Obesity Other: cellvizio

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Identification of In-vivo Probe Based Confocal Laser Endomicroscopy (pCLE) Gastric & Duodenal Cellular Characteristics in Obese Women Before & After Weight Reduction

Further study details as provided by Dr. Ofir Harnoy MD, Sheba Medical Center:

Primary Outcome Measures:
  • tissue morphology [ Time Frame: 3 months ]
    pCLE morphological characteristics of gastric and duodenal cells in obese individuals, before and after sleeve gastrectomy (when weight loss is achieved)


Estimated Enrollment: 10
Study Start Date: June 2016
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: cellvizio
    pCLE during gastroscopy
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obese patients, referred for bariatric sleeve gastrectomy.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781961


Contacts
Contact: OFIR HAR-NOY, MD 972-3-5302679 ofirharnoy@gmail.com

Locations
Israel
Sheba Medical Center Recruiting
Tel HaShomer, Israel, 52621
Contact: Ofir Har-Noy, MD    +972-3-530-2679    ofirharnoy@gmail.com   
Principal Investigator: Ofir Har-Noy, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: OFIR HAR-NOY, MD Sheba Medical Center
  More Information

Responsible Party: Dr. Ofir Harnoy MD, Dr, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02781961     History of Changes
Other Study ID Numbers: SMC-15-2353
First Submitted: May 17, 2016
First Posted: May 25, 2016
Last Update Posted: October 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No