Intestinal MetaplasiaNCT02695186
Oxidative Stress in Intestinal Metaplasia and Metabolic Syndrome
An observational study of Intestinal Metaplasia and Metabolic Syndrome, run by General Hospital of Filiates at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Metaplasia, Metabolic Syndrome, Oxidative Stress
- What is being tested?
- Gastroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2016to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of metabolic syndrome, Must be able to undergo gastroscopy,
- Must be >25 and <75 years old
Who cannot join
- Autoimmune diseases, Malignancy, Chronic kidney disease, Type 2 diabetes complications
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
General Hospital of Filiates
Filiátes, Epirus, 46300
Georgios Pappas-Gogos, MD, MSc, +302663360227, pappasg8@gmail.com
Georgios Pappas-Gogos, MD, MSc
About this study
Official title: Markers of Oxidative Stress and Inflammation in Patients With Intestinal Metaplasia and Metabolic Syndrome
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.
Read more
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
Read the detailed description
INTRODUCTION:
Intestinal metaplasia (IM) is considered a precancerous lesion and is associated with a very small increase of gastric cancer risk. Generally there are no widely accepted guidelines on the IM management. Recently, the European Endoscopic Society and other European academic companies have developed evidence-based guidelines for the management of patients with IM. These instructions highlighted the increased risk of cancer in patients with gastric atrophy and IM and the need for staging in cases with high-grade dysplasia. Risk factors for IM include infection with Helicobacter pylori, high NaCl intake, smoking, alcohol consumption and chronic bile reflux. The four steps sequence of the events for the development of the intestinal type gastric adenocarcinoma include: Non-atrophic gastritis, multifocal atrophic gastritis, IM, and dysplasia.
Reactive oxygen species (ROS) are produced as by-products of the normal metabolism of the cell. ROS are generated in response to ultraviolet radiation, smoking, alcohol, nonsteroidal anti-inflammatories, ischemia-reperfusion, chronic infections and chronic inflammatory disorders. Disruption of the normal homeostasis of the cell, due to changes in redox homeostasis can lead to the development of cardiovascular diseases, neurodegenerative diseases and cancer. 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. Despite the protective barrier provided by the digestive mucosa, different molecules which may be present in the content of GI,as well as various pathogens can cause oxidative damage and inflammatory response in the intestinal mucosa and the immune cells. Pathogenesis of various GI diseases, including ulcerative lesions, cancer, and inflammatory bowel diseases are attributable in part to oxidative stress. 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.
On the other hand, since chronic inflammation has been recognized as an important risk factor for the development of GI tumors, the underlying molecular mechanisms have been studied extensively. Chronic inflammation may induce cell mutations and promote malignant transformation in normal cells of the GI mucosa. The inflammatory reaction generated during carcinogenesis involves the formation of reactive oxygen and nitrogen species (ROS and RNS) derived from mononuclear phagocytes and lymphocytes, as well as the development of immune response, and the production of pro-inflammatory cytokines. Nuclear factor-κB (NF-κB) is considered as the main mediator of the immune response. The activation of NF-κB through phosphorylation leads to translocation of NF-κB in the nucleus, where regulates the transcription of several pro-inflammatory cytokines and chemokines. Furthermore, chronic inflammation can create the appropriate conditions for genomic and epigenetic changes.
Obesity, particularly abdominal obesity, is associated with insulin resistance in the peripheral tissues and abnormal fatty acid metabolism, often leading to type 2 diabetes mellitus (DM2) development. Insulin resistance, hyperinsulinemia, hypoglycemia and cytokine production by adipocytes (adipokines) can also result in endothelial dysfunction, disorders of the lipid profile, hypertension and vascular inflammation, which promote the development of atherosclerotic cardiovascular disease. In patients with coexistence of metabolic risk factors for DM2 and cardiovascular disease (abdominal obesity, hyperglycemia, dyslipidemia and hypertension) suggested the existence of "metabolic syndrome". 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. Furthermore, no causal relationship between increased levels of CRP levels and MS incidence has been found. The value of several markers for the monitoring of patients with MS remain uncertain.The use of these markers should be made for clinical purposes only, with respect to the determination of cardiovascular risk assessment. The guidelines of the Centers for Disease Control and Prevention (CDC) emphasize that the analysis of CRP still belongs to the optional tests, because the power as an independent predictive remains uncertain.
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. The reduction of antioxidant capacity in individuals with IM can be explained by the concomitant overproduction of ROS and their metabolites (d-ROMS), the decreased activity of the enzymes that neutralize ROS (SOD, CAT and GPx) and reduction of other antioxidant systems, such as PON1 activity. Recently, γGT has been suggested as a promising biomarker for the diagnosis of MS, and its levels in serum may reflect the response to oxidative stress.
Moreover, the correlation between the SOD and the various active moieties in MS may indicate that the SOD activity could be a better biomarker of oxidative stress in these patients. The measurement of the SOD activity could be used as a predictive tool for determining the extent of the underlying oxidative stress in the disease. These findings suggest that the study of the oxidative state in the earlier phases of MS may be the starting point for understanding the pathways that contribute to the progress of the MS and its subsequent complications. 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. It seems that increased oxidative stress is the main mechanism behind the increased tendency to develop cardiovascular disease, greater severity of cardiovascular disease in younger people and poorer treatment outcomes.
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. If these findings will be confirmed in prospective studies, patients with MS could form a high-risk group for developing Barett's esophagus and esophageal adenocarcinoma. The prevalence of MS concerning the development of Barett's esophagus and particularly the relationship between the length of damage and changes in the levels of leptin, insulin and proinflammatory markers, indicate that the changes caused by the development of Barrett's esophagus are constant and are affected by metabolic changes caused by adipokines and cytokines. 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.
AIM OF THE STUDY:
This study aim the analysis of oxidative stress markers and markers of inflammation in patients with IM and MS, patients with IM alone, and healthy volunteers, as well as the impact of therapeutic protocols, and the association of the markers with the extension of the lesion.
MATERIALS AND METHODS:
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.
- Being tested
- Gastroscopy
- Keywords
- Intestinal metaplasia, Metabolic syndrome, Oxidative stress
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastroscopyProcedure or surgery
Gastroscopy and biopsies, as well as blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| A/IM alone | Patients with intestinal metaplasia who undergo gastroscopy and blood sample analysis Receives: Procedure: Gastroscopy | |
| B/IM and MS | Patients with intestinal metaplasia and metabolic syndrome who undergo gastroscopy and blood sample analysis Receives: Procedure: Gastroscopy | |
| C/Healthy controls | Healthy controls without intestinal metaplasia or metabolic syndrome who undergo gastroscopy and blood sample analysis Receives: Procedure: Gastroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
8-epiPGF2α (pg/ml)
Marker of lipid peroxidation
Measured: Baseline
8-OHG (ng/ml)
Marker of RNA oxidation
Measured: Baseline
Total antioxidant capacity (TAC) (mM)
Measurement of antioxidant concentration (Uric acid, ascorbic acid, Vitamin E, BHT, Triolox, GSH, BSA/PBS)
Measured: Baseline
Total cholesterol (mg/dl)
Measured: Baseline
LDL-C (mg/dL)
Measured: Baseline
HDL-C (mg/dL)
Measured: Baseline
Triglycerides (TRG) (mg/dL)
Measured: Baseline
BMI (kg/height2)
Measured: Baseline
Plasma glucose (mg/dL)
Measured: Baseline
Plasma glycated hemoglobin A1c (%)
Measured: Baseline
Secondary outcomes (1)
Correlation between markers of oxidative stress and extension of the gastric lesion
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intestinal MetaplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Filiates
- Sponsor type
- Other government
- Collaborators
- University of Ioannina
- Responsible party
- Sponsor
- Investigators
- Georgios Pappas-Gogos, MD, MSc, Principal investigator, Filiates General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695186
- Sponsor's protocol ID
- 1/21/01/2016
- Status last verified
- Feb 2016
- First submitted
- 19 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 20203636Chandrasoma 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.
PubMed 17227308Bhattacharyya 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.
PubMed 24692350Sihvo 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.
PubMed 12447994Meigs 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.
PubMed 11092432Hutcheson 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.
PubMed 22829804
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Oxidative Stress and Inflammation in Patients With Intestinal Metaplasia and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT02695186
- Acronym / sponsor ID
- 1/21/01/2016
- Keywords
- Intestinal metaplasia, Metabolic syndrome, Oxidative stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- General Hospital of FiliatesOther government
- Collaborators
- University of Ioannina
- Study start
- Feb 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 1 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
INTRODUCTION:
Intestinal metaplasia (IM) is considered a precancerous lesion and is associated with a very small increase of gastric cancer risk. Generally there are no widely accepted guidelines on the IM management. Recently, the European Endoscopic Society and other European academic companies have developed evidence-based guidelines for the management of patients with IM. These instructions highlighted the increased risk of cancer in patients with gastric atrophy and IM and the need for staging in cases with high-grade dysplasia. Risk factors for IM include infection with Helicobacter pylori, high NaCl intake, smoking, alcohol consumption and chronic bile reflux. The four steps sequence of the events for the development of the intestinal type gastric adenocarcinoma include: Non-atrophic gastritis, multifocal atrophic gastritis, IM, and dysplasia.
Reactive oxygen species (ROS) are produced as by-products of the normal metabolism of the cell. ROS are generated in response to ultraviolet radiation, smoking, alcohol, nonsteroidal anti-inflammatories, ischemia-reperfusion, chronic infections and chronic inflammatory disorders. Disruption of the normal homeostasis of the cell, due to changes in redox homeostasis can lead to the development of cardiovascular diseases, neurodegenerative diseases and cancer. 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. Despite the protective barrier provided by the digestive mucosa, different molecules which may be present in the content of GI,as well as various pathogens can cause oxidative damage and inflammatory response in the intestinal mucosa and the immune cells. Pathogenesis of various GI diseases, including ulcerative lesions, cancer, and inflammatory bowel diseases are attributable in part to oxidative stress. 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.
On the other hand, since chronic inflammation has been recognized as an important risk factor for the development of GI tumors, the underlying molecular mechanisms have been studied extensively. Chronic inflammation may induce cell mutations and promote malignant transformation in normal cells of the GI mucosa. The inflammatory reaction generated during carcinogenesis involves the formation of reactive oxygen and nitrogen species (ROS and RNS) derived from mononuclear phagocytes and lymphocytes, as well as the development of immune response, and the production of pro-inflammatory cytokines. Nuclear factor-κB (NF-κB) is considered as the main mediator of the immune response. The activation of NF-κB through phosphorylation leads to translocation of NF-κB in the nucleus, where regulates the transcription of several pro-inflammatory cytokines and chemokines. Furthermore, chronic inflammation can create the appropriate conditions for genomic and epigenetic changes.
Obesity, particularly abdominal obesity, is associated with insulin resistance in the peripheral tissues and abnormal fatty acid metabolism, often leading to type 2 diabetes mellitus (DM2) development. Insulin resistance, hyperinsulinemia, hypoglycemia and cytokine production by adipocytes (adipokines) can also result in endothelial dysfunction, disorders of the lipid profile, hypertension and vascular inflammation, which promote the development of atherosclerotic cardiovascular disease. In patients with coexistence of metabolic risk factors for DM2 and cardiovascular disease (abdominal obesity, hyperglycemia, dyslipidemia and hypertension) suggested the existence of "metabolic syndrome". 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. Furthermore, no causal relationship between increased levels of CRP levels and MS incidence has been found. The value of several markers for the monitoring of patients with MS remain uncertain.The use of these markers should be made for clinical purposes only, with respect to the determination of cardiovascular risk assessment. The guidelines of the Centers for Disease Control and Prevention (CDC) emphasize that the analysis of CRP still belongs to the optional tests, because the power as an independent predictive remains uncertain.
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. The reduction of antioxidant capacity in individuals with IM can be explained by the concomitant overproduction of ROS and their metabolites (d-ROMS), the decreased activity of the enzymes that neutralize ROS (SOD, CAT and GPx) and reduction of other antioxidant systems, such as PON1 activity. Recently, γGT has been suggested as a promising biomarker for the diagnosis of MS, and its levels in serum may reflect the response to oxidative stress.
Moreover, the correlation between the SOD and the various active moieties in MS may indicate that the SOD activity could be a better biomarker of oxidative stress in these patients. The measurement of the SOD activity could be used as a predictive tool for determining the extent of the underlying oxidative stress in the disease. These findings suggest that the study of the oxidative state in the earlier phases of MS may be the starting point for understanding the pathways that contribute to the progress of the MS and its subsequent complications. 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. It seems that increased oxidative stress is the main mechanism behind the increased tendency to develop cardiovascular disease, greater severity of cardiovascular disease in younger people and poorer treatment outcomes.
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. If these findings will be confirmed in prospective studies, patients with MS could form a high-risk group for developing Barett's esophagus and esophageal adenocarcinoma. The prevalence of MS concerning the development of Barett's esophagus and particularly the relationship between the length of damage and changes in the levels of leptin, insulin and proinflammatory markers, indicate that the changes caused by the development of Barrett's esophagus are constant and are affected by metabolic changes caused by adipokines and cytokines. 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.
AIM OF THE STUDY:
This study aim the analysis of oxidative stress markers and markers of inflammation in patients with IM and MS, patients with IM alone, and healthy volunteers, as well as the impact of therapeutic protocols, and the association of the markers with the extension of the lesion.
MATERIALS AND METHODS:
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A/IM alone | – | Procedure: GastroscopyPatients with intestinal metaplasia who undergo gastroscopy and blood sample analysis |
| B/IM and MS | – | Procedure: GastroscopyPatients with intestinal metaplasia and metabolic syndrome who undergo gastroscopy and blood sample analysis |
| C/Healthy controls | – | Procedure: GastroscopyHealthy controls without intestinal metaplasia or metabolic syndrome who undergo gastroscopy and blood sample analysis |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Clinical diagnosis of metabolic syndrome, Must be able to undergo gastroscopy,
- Must be >25 and <75 years old
Key exclusion criteria (1 listed)
- Autoimmune diseases, Malignancy, Chronic kidney disease, Type 2 diabetes complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastroscopyGastroscopy and biopsies, as well as blood sample collection | Procedure or surgery | A/IM alone, B/IM and MS, C/Healthy controls |
Primary outcome
8-epiPGF2α (pg/ml)
Time frame: Baseline
Marker of lipid peroxidation
8-OHG (ng/ml)
Time frame: Baseline
Marker of RNA oxidation
Total antioxidant capacity (TAC) (mM)
Time frame: Baseline
Measurement of antioxidant concentration (Uric acid, ascorbic acid, Vitamin E, BHT, Triolox, GSH, BSA/PBS)
Total cholesterol (mg/dl)
Time frame: Baseline
LDL-C (mg/dL)
Time frame: Baseline
HDL-C (mg/dL)
Time frame: Baseline
Triglycerides (TRG) (mg/dL)
Time frame: Baseline
BMI (kg/height2)
Time frame: Baseline
Plasma glucose (mg/dL)
Time frame: Baseline
Plasma glycated hemoglobin A1c (%)
Time frame: Baseline
1 secondary outcome
Correlation between markers of oxidative stress and extension of the gastric lesion
Time frame: Through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Background: PubMed 20203636Correa 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.
- Background: PubMed 17227308Chandrasoma 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.
- Background: PubMed 24692350Bhattacharyya 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.
- Background: PubMed 12447994Sihvo 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.
- Background: PubMed 11092432Meigs 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.
- Background: PubMed 22829804Hutcheson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Pappas-Gogos, MD, MSc principal investigator
Filiates General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Metaplasia and Metabolic Syndrome, run by General Hospital of Filiates at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgios Pappas-Gogos, MD, MSc (+306973397398, pappasg8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
8-epiPGF2α (pg/ml) (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02695186, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.