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

NCT02781961 | Terminated DMC

• 1 other identifier: SMC-15-2353
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

cellvizio OTHER

pCLE during gastroscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients, referred for bariatric sleeve gastrectomy.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• OFIR HAR-NOY, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 25, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)