Oxidative Stress in Intestinal Metaplasia and Metabolic Syndrome

NCT02695186 | Unknown DMC

• 1 other identifier: 1/21/01/2016
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Intestinal metaplasia is generally considered a precancerous lesion. Although it is associated with a very small increase of gastric cancer risk, European Endoscopic Society and other European academic companies highlighted the increased risk of cancer in patients with gastric atrophy and IM and the need for staging in cases with high-grade dysplasia. The production of ROS in the gastrointestinal tract (GI) and their role in the pathophysiology and pathogenesis of gastrointestinal diseases have not been studied sufficiently. In the plasma of patients, in the context of the sequence gastro oesophageal reflux-oesophagitis-metaplasia-dysplasia-adenocarcinoma, have been found simultaneous formation of DNA adducts and increased myeloperoxidase concentration, which are associated with oxidative stress, decreased antioxidant capacity (decreased glutathione concentration).These findings support the role of oxidative stress in the pathogenesis and malignant transformation. Metabolic Syndrome (MS) has been recognized as a pro-inflammatory, pro-coagulant state associated with increased levels of C reactive protein (CRP), interleukin (IL) 6 and plasminogen activator inhibitor (PAI) 1. It has been reported that the inflammatory and the pro thrombotic markers, which are associated with increased risk for cardiovascular disease and DM2, represent only a part of the relationship between IM and cardiovascular mortality. Several factors influence the pathogenesis of MS, as the pro-oxidant condition of such patients may increase the risk for developing symptoms and related chronic diseases such as DM2. Although the exact contribution of oxidative stress on every pathologic condition included in MS is difficult to determine definitively, it is certain that oxidative stress is particularly high in the MS. Regarding the relationship between MS and GI diseases, studies have reported that patients with MS are almost twice at risk for developing Barrett's esophagus.The relationship between MS, gastro-esophageal reflux disease (GERD), and the development of IM also requires well designed prospective studies. It seems however, to be a correlation between obesity and GERD, as well as between obesity and gastric adenocarcinoma

Conditions

Intestinal Metaplasia; Metabolic Syndrome; Oxidative Stress; Inflammatory Response

Keywords

Intestinal metaplasia; Metabolic syndrome; Oxidative stress

Outcome Measures

Primary Outcomes (10)

• 8-epiPGF2α (pg/ml)

  Marker of lipid peroxidation

  Baseline

• 8-OHG (ng/ml)

  Marker of RNA oxidation

  Baseline

• Total antioxidant capacity (TAC) (mM)

  Measurement of antioxidant concentration (Uric acid, ascorbic acid, Vitamin E, BHT, Triolox, GSH, BSA/PBS)

  Baseline

• Total cholesterol (mg/dl)

  Baseline

• LDL-C (mg/dL)

  Baseline

• HDL-C (mg/dL)

  Baseline

• Triglycerides (TRG) (mg/dL)

  Baseline

• BMI (kg/height2)

  Baseline

• Plasma glucose (mg/dL)

  Baseline

• Plasma glycated hemoglobin A1c (%)

  Baseline

Secondary Outcomes (1)

• Correlation between markers of oxidative stress and extension of the gastric lesion

  Through study completion, an average of 6 months

Study Arms (3)

A/IM alone

Patients with intestinal metaplasia who undergo gastroscopy and blood sample analysis

Procedure: Gastroscopy

B/IM and MS

Patients with intestinal metaplasia and metabolic syndrome who undergo gastroscopy and blood sample analysis

Procedure: Gastroscopy

C/Healthy controls

Healthy controls without intestinal metaplasia or metabolic syndrome who undergo gastroscopy and blood sample analysis

Procedure: Gastroscopy

Interventions

Gastroscopy PROCEDURE

Gastroscopy and biopsies, as well as blood sample collection

A/IM alone; B/IM and MS; C/Healthy controls

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A group of patients with IM and MS, a group of patients with IM alone, and a group of healthy volunteers. Every group of patients will be divided in subgroups based on age and gender.

You may qualify if:

• Clinical diagnosis of metabolic syndrome, Must be able to undergo gastroscopy,
• Must be \>25 and \<75 years old

You may not qualify if:

• Autoimmune diseases, Malignancy, Chronic kidney disease, Type 2 diabetes complications

Sponsors & Collaborators

• General Hospital of Filiates: lead
• University of Ioannina: collaborator

Study Sites (1)

General Hospital of Filiates

Filiátes, Epirus, 46300, Greece

RECRUITING

Related Publications (6)

• Correa P, Piazuelo MB, Wilson KT. Pathology of gastric intestinal metaplasia: clinical implications. Am J Gastroenterol. 2010 Mar;105(3):493-8. doi: 10.1038/ajg.2009.728. No abstract available.

  PMID: 20203636 BACKGROUND

• Chandrasoma P, Wickramasinghe K, Ma Y, DeMeester T. Is intestinal metaplasia a necessary precursor lesion for adenocarcinomas of the distal esophagus, gastroesophageal junction and gastric cardia? Dis Esophagus. 2007;20(1):36-41. doi: 10.1111/j.1442-2050.2007.00638.x.

  PMID: 17227308 BACKGROUND

• Bhattacharyya A, Chattopadhyay R, Mitra S, Crowe SE. Oxidative stress: an essential factor in the pathogenesis of gastrointestinal mucosal diseases. Physiol Rev. 2014 Apr;94(2):329-54. doi: 10.1152/physrev.00040.2012.

  PMID: 24692350 BACKGROUND

• Sihvo EI, Salminen JT, Rantanen TK, Ramo OJ, Ahotupa M, Farkkila M, Auvinen MI, Salo JA. Oxidative stress has a role in malignant transformation in Barrett's oesophagus. Int J Cancer. 2002 Dec 20;102(6):551-5. doi: 10.1002/ijc.10755.

  PMID: 12447994 BACKGROUND

• Meigs JB. Invited commentary: insulin resistance syndrome? Syndrome X? Multiple metabolic syndrome? A syndrome at all? Factor analysis reveals patterns in the fabric of correlated metabolic risk factors. Am J Epidemiol. 2000 Nov 15;152(10):908-11; discussion 912. doi: 10.1093/aje/152.10.908.

  PMID: 11092432 BACKGROUND

• Hutcheson R, Rocic P. The metabolic syndrome, oxidative stress, environment, and cardiovascular disease: the great exploration. Exp Diabetes Res. 2012;2012:271028. doi: 10.1155/2012/271028. Epub 2012 Jul 9.

  PMID: 22829804 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Georgios Pappas-Gogos, MD, MSc

  Filiates General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios Pappas-Gogos, MD, MSc

CONTACT

+306973397398; pappasg8@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 1, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 1, 2016

Record last verified: 2016-02

Locations

GR (1)