NCT04084886

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

September 10, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

September 3, 2019

Last Update Submit

September 7, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • cardiovascular disease
  • diabetic neuropathy
  • diabetic retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 29371774BACKGROUND
  • 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. No abstract available.

    PMID: 28579156BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Central Study Contacts

Madeeha Younis

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 10, 2019

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

October 1, 2020

Last Updated

September 10, 2019

Record last verified: 2019-09