TCF7L2 Gene Polymorphism and AGEs in Diabetic Nephropathy

September 7, 2019 updated by: Ghadeer abdelrazzak mohammed, Assiut University

Transcription Factor 7 Like 2 Gene Polymorphism and Advanced Glycation End Products as Risk Factors for Diabetic Nephropathy

  1. To study genotypic distribution of the TCF7L2 gene polymorphism in Diabetic nephropathy.
  2. To assess level of AGEs and Insulin in patients with Diabetic nephropathy.
  3. To study correlation between polymorphism of the TCF7L2 gene, AGEs, Insulin and clinical characteristics in patients with diabetic nephropathy

Study Overview

Status

Unknown

Conditions

Detailed Description

Diabetic nephropathy is one of microvascular complications of diabetes mellitus. DN is a multifactorial disorder that occurs in one third of patients with long standing DM. DN is one of the most serious complications that being a major contributing factor to end-stage renal disease and death in diabetic patients. The earliest clinical indication of DN is the appearance of microalbuminuria. Detection of diabetic nephropathy as early as possible, is the best chance of delaying progression to ESRD. Thus, screening for microalbuminuria is recommended annually immediately after a diagnosis of diabetes. Transcription factor 7-like 2 is a highly variable transcription factor, which is a key component of the Wnt-signaling pathway and plays a role in the regulation of insulin secretion by pancreatic beta cells and the maintenance of glucose homeostasis. TCF7L2 rs7903146 polymorphism is more associated with T2DM which mediated by decreased insulin secretion associated with defects in insulin processing, reduced effects of glucagon-like peptide-1, increased hepatic glucose production and insulin resistance. The mutant TT genotype and the T allele frequency was associated with diabetic patients who developed nephropathy. Advanced glycation end products are generated by the non-enzymatic reaction of amino groups in DNA and proteins with reducing sugars. AGEs accumulate in glomerular basement membrane. The AGEs-RAGE interaction is a causative factor for DN through activating a series of intracellular signal-cascade pathways which induce the generation of further signalling factors, such as vascular endothelial growth factor, transforming growth factor B, nuclear factor-κβ. Those signalling factors cause mesangial expansion and glomerulosclerosis.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • 60 diabetic patients: Diagnosis of DM was based on the American Diabetes Association Criteria:

    -The diabetic patients will be classified into 2 subgroups:

  • 30 Diabetic patients without any microvascular or macrovascular complications.
  • 30 Diabetic patients with pure nephropathy not having other microvascular or macrovascular complications.
  • 20 patients diagnosed as prediabetes:
  • Beside 20 Apparent healthy subjects as control group.

Description

Inclusion Criteria:

  • diabetic nephropathy
  • clinical diagnosis of prediabetes
  • Type 2 diabetic patients

Exclusion Criteria:

  • cardiovascular disease
  • diabetic neuropathy
  • diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of diabetic nephropathy
Time Frame: one year

find a link between genetic polymorphism of TCF7L2 and the risk of developing nephropathy in diabetic patients.

Nephropathy is defined Albumin/creatinine ratio > 30 mg/gm creat.
one year
Number of patients with genotype TCF7L2 by PCR
Time Frame: 5 years

the prevalence of TCF7L2, in the diabetic patient, and compared to the values found in the general population.

the TCF7L2 genes will be evaluated by PCR-RFLP
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2019

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

September 3, 2019

First Submitted That Met QC Criteria

September 7, 2019

First Posted (Actual)

September 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 7, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCF7L2 in Diabetic nephropathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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