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TCF7L2 Gene Polymorphism and AGEs in Diabetic Nephropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04084886
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : September 10, 2019
Information provided by (Responsible Party):
Ghadeer abdelrazzak mohammed, Assiut University

Brief Summary:
  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

Condition or disease
Diabetic Nephropathies

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Transcription Factor 7 Like 2 Gene Polymorphism and Advanced Glycation End Products as Risk Factors for Diabetic Nephropathy
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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.

Inclusion Criteria:

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

Exclusion Criteria:

  • cardiovascular disease
  • diabetic neuropathy
  • diabetic retinopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04084886

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Contact: Ghadeer Abdelrazzak 01011676458
Contact: Madeeha Younis 01009344150

Sponsors and Collaborators
Assiut University
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Responsible Party: Ghadeer abdelrazzak mohammed, Assistant lecturer, Assiut University Identifier: NCT04084886    
Other Study ID Numbers: TCF7L2 in Diabetic nephropathy
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases