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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04084886
Other study ID # TCF7L2 in Diabetic nephropathy
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date October 2020

Study information

Verified date September 2019
Source Assiut University
Contact Ghadeer Abdelrazzak
Phone 01011676458
Email ghadeer.razzak111@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date October 2020
Est. primary completion date September 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- diabetic nephropathy

- clinical diagnosis of prediabetes

- Type 2 diabetic patients

Exclusion Criteria:

- cardiovascular disease

- diabetic neuropathy

- diabetic retinopathy

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Adamska E, Kretowski A, Goscik J, Citko A, Bauer W, Waszczeniuk M, Maliszewska K, Paczkowska-Abdulsalam M, Niemira M, Szczerbinski L, Ciborowski M, Gorska M. The type 2 diabetes susceptibility TCF7L2 gene variants affect postprandial glucose and fat utilization in non-diabetic subjects. Diabetes Metab. 2018 Sep;44(4):379-382. doi: 10.1016/j.diabet.2017.05.001. Epub 2017 May 31. — View Citation

Gawandi S, Gangawane S, Chakrabarti A, Kedare S, Bantwal K, Wadhe V, Kulkarni A, Kulkarni S, Rajan MGR. A Study of Microalbuminuria (MAU) and Advanced Glycation End Products (AGEs) Levels in Diabetic and Hypertensive Subjects. Indian J Clin Biochem. 2018 Jan;33(1):81-85. doi: 10.1007/s12291-017-0638-5. Epub 2017 Feb 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of diabetic nephropathy 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
Primary Number of patients with genotype TCF7L2 by PCR 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
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