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Type1diabetesNCT05874323

The Relationship of RAGE Gene Polymorphism With Type I Diabetes in Egyptian Patients

A study testing Detection of RAGE gene polymorphism (rs1800625) in people with Type1diabetes, run by Future University in Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type I Diabetes Mellitus (TIDM) is a chronic metabolic disorder caused by the immune-mediated T-cell and macrophages that typically affects insulin-producing β-cells of Langerhans leading to cell destruction and absolute insulin deficiency. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Type1diabetes
What is being tested?
Detection of RAGE gene polymorphism (rs1800625)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
1 siteEgypt
Study dates
1 Jan 2023to 10 May 2023
Phase
Interventional
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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • <18 Years

Who cannot join

  • > 65

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • National Institute of Diabetes and Endocrinology's

    Cairo, 11817

Other trials in Egypt

About this study

Official title: The Relationship of RAGE Gene Polymorphism (rs1800625) With Type I Diabetes Mellitus Incidence, Severity, and Inflammatory Reactions in Egyptian Patients on MicroRNAs (MiRNA-34, MiRNA-146): A Case-control Study

Type I Diabetes Mellitus (TIDM) is a chronic metabolic disorder caused by the immune-mediated T-cell and macrophages that typically affects insulin-producing β-cells of Langerhans leading to cell destruction and absolute insulin deficiency. This study aimed to investigate the correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes mellitus in the Egyptian patients with the activity and the severity of the disease and to assess their association with inflammatory reactions in TIDM patients (IL-6, TNF-α). Also, this study investigated the relation between MiRNA-34, MiRNA-146, to TID severity and activity

Read the detailed description

Type I diabetes mellitus (TIDM) is also called autoimmune diabetes, juvenile-onset or insulin-dependent diabetes mellitus . It is representing 10% of diabetes cases, estimated that most of these patients are less than 15 years old. The pathophysiology of TIDM is a complex and available data proposed the important cause for this disease such as autoimmune disease and some genetic factors TIDM is a chronic disease caused by the immune-mediated T-cell and macrophages attack on insulin-producing β-cells of Langerhans leading to cell destruction and absolute insulin deficiency. This will produce high blood sugar (hyperglycemia) and change in the proteins and lipids metabolism TIDM is usually characterized by the presence of anti-glutamic acid decarboxylase, islet of β-cell or insulin antibodies which identify the autoimmune processes, leads to β-cell destruction .

Type I diabetes mellitus is account for only a minority of the total burden of diabetes in a population, however it is considered the major type of diabetes in younger age .

Treatment of TIDM is more complex than other types of diabetes, as it cannot be regulated only by dietary interventions, as it is usually accompanied by severe complications, and has extreme variability due to the diverse ages of diagnosis. Primary treatment for TIDM include immune-suppressive drugs and continuous exogenous insulin that cover the primary pathophysiology of TIDM Currently, diabetes mellitus is diagnosed when hemoglobin A1C (HbA1c) is ≥6.5% or fasting plasma glucose (FPG) is ≥ 126 mg/dl or 2 hour postprandial plasma glucose is ≥ 200 mg/dl during an oral glucose tolerance test or a random plasma glucose is ≥ 200 mg/dl plus symptoms of diabetes .

Advanced glycation end products (AGEs) Advanced glycation end products (AGEs) are defined as a heterogeneous group of irreversibly reactive derivatives. They are formed by non-enzymatic glycation with tissue proteins, and shown to accumulate on long-lived proteins in diabetes mellitus . They generate oxidative stress and induce inflammation and they have been tied to be a factor in the development an unfavorable pro-inflammatory state implicated in many degenerative diseases, such as autoimmune diseases, diabetes, atherosclerosis, chronic renal failure, metabolic syndrome and its complications, and neurological diseases such as Alzheimer's disease, cardiovascular diseases (Kuzan and Aleksandra 2021). These harmful compounds can affect every type of cell in the body and are thought to be one factor in some age-related chronic diseases. Receptor for advanced glycation end products (RAGE) is a multi-ligand cell surface receptor that belongs to the immunoglobulin superfamily. RAGE activation by various ligands have been reported to induce LDL deposition, resulting in foam cell formation . Furthermore, it increase oxidative stress generation and subsequently increase inflammatory, proliferative, angiogenic, fibrotic, thrombogenic, and apoptotic reactions in numerous cell types via activation of many intracellular signaling pathways such as nuclear factor-κB (NF-κB) . RAGE expression is usually low in the majority of healthy adult tissues, but its levels are elevated under pathological conditions such as diabetes .

RAGE is a highly polymorphic gene, with around ten polymorphisms being predominantly studied. The genetic variations of RAGE should be considered as responsible for the development of many diseases (Serveaux et al., 2019). In addition, combining RAGE-circulating protein levels and RAGE polymorphisms may be used as a useful clinical tool to predict risk of vascular diseases. Indeed, sRAGE could be a valuable biomarker in many pathological states. It increases in patients with decreased renal function, and decreases in diabetic complications and coronary artery disease, but also elevated levels of sRAGE are often associated with end-stage disease . The genetic background of RAGE demonstrated that some gene polymorphisms are implicated in various pathological states, for example, diabetes complications, amplification of the inflammatory response, gastric cancer, and breast cancer . Recently, five main RAGE polymorphisms described (rs2070600, rs1800624, rs184003, and a 63 bp deletion) were not associated with either type 1 or type 2 diabetes . In this study, we focused on the principal RAGE polymorphism (rs1800625) and their potential pathological effect depending on the study of the Egyptian population with TIDM.

Rs1800625 Polymorphism The rs1800625 SNP (- 429 T > C) located in the upstream region and was found to increase the transcription of RAGE around twofold in vitro and so increase the RAGE expression, which might influence the pathogenesis of many diseases such as autoimmune and inflammatory diseases (Ahuja el al., 2022). In the presence of rs1800625 polymorphism, it is not only a higher expression of sRAGE but also, there is an increase of AGEs. Studies on different pathologies (inflammatory disease, cancer, coronary artery disease, lung disease, and myocardial infarction) focused on rs1800625, but with conflicting results. However the rs1800625 SNP was studied in different types of cancer but founded to be not involved in the pathogenesis of pancreatic cancer like RAGE is implicated There were numerous studies of SNP rs1800625 in diabetic patients, but with conflicting results. The rs1800625 SNP was significantly increased in type 2 diabetes subjects with retinopathy, compared to those without . Many studies demonstrated a correlation between rs1800625 polymorphism and diabetic complications. The rs1800625 and rs3134940 were founded to be increase (+65%) the risk of developing diabetic nephropathy and was associated with its early onset. The rs1800625 SNP was also associated with the development of insulin resistance, and in a Brazilian population there was a two-fold increase in the incidence of rs1800625 when subjects were diabetic. An analysis in infants with type I diabetes from the Finn Diane cohort reported that rs1800625 was more prevalent in type I diabetic patients than in controls . In diabetic subjects, rs1800625 was associated with higher HbA1c levels, with an increased incidence of type 1 diabetes.

The association of rs1800625 with cardiovascular risk has been evaluated, with again controversial results. The rs1800625 was associated with higher levels of circulating form of (RAGE) and an increased risk of developing coronary artery disease, especially in diabetic patients

Conditions
Type1diabetes
Being tested
Detection of RAGE gene polymorphism (rs1800625)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Detection of RAGE gene polymorphism (rs1800625)Genetic

    Detection of RAGE gene polymorphism (rs1800625) By Molecular analysis (real time PCR)

Study groups in NCT05874323
Study groupRoleWhat they receive
Type I Diabetes MellitusExperimental177 patients with Type I Diabetes Mellitus
Receives: Genetic: Detection of RAGE gene polymorphism (rs1800625)
ControlOtherinclude 177 Healthy Control Cases.
Receives: Genetic: Detection of RAGE gene polymorphism (rs1800625)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes

    correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes using the TaqMan genotyping assay in the study population. Tumor necrosis factor-alpha (TNF-α), interleukin (IL-6) serum levels, and clinical parameters were measured using the enzyme-linked immunosorbent assay (ELISA) technique.

    Measured: 4 months

Secondary outcomes (1)
  1. the relation between MiRNA-34, MiRNA-146, to TID severity and activity.

    the relation between MiRNA-34, MiRNA-146, to TID severity and activity. 146 were determined using quantitative real-time PCR (qPCR)

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start1 Jan 2023
  3. Primary completion10 May 2023
  4. Study completion10 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
354 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05874323
Sponsor's protocol ID
IDE00296
Status last verified
Aug 2023
First submitted
13 May 2023
Last updated
23 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Detection of RAGE gene polymorphism (rs1800625) in people with Type1diabetes, run by Future University in Egypt at 1 site in Egypt.

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 1 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: finished, as of the sponsor's last update on 23 Aug 2023. 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 Egypt. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation of RAGE gene polymorphism rs1800625 with the incidence of type I diabetes (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 23 Aug 2023.

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