Diabetic NephropathiesNCT04084886
TCF7L2 Gene Polymorphism and AGEs in Diabetic Nephropathy
An observational study of Diabetic Nephropathies, run by Assiut University.
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathies
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to Oct 2020
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- diabetic nephropathy
- clinical diagnosis of prediabetes
- Type 2 diabetic patients
Who cannot join
- cardiovascular disease
- diabetic neuropathy
- diabetic retinopathy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transcription Factor 7 Like 2 Gene Polymorphism and Advanced Glycation End Products as Risk Factors for Diabetic Nephropathy
- To study genotypic distribution of the TCF7L2 gene polymorphism in Diabetic nephropathy.
- To assess level of AGEs and Insulin in patients with Diabetic nephropathy.
- To study correlation between polymorphism of the TCF7L2 gene, AGEs, Insulin and clinical characteristics in patients with diabetic nephropathy
Read the 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.
- Conditions
- Diabetic Nephropathies
- Medical subject headings
- Diabetic Nephropathies
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start1 Sep 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic NephropathiesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer abdelrazzak mohammed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084886
- Sponsor's protocol ID
- TCF7L2 in Diabetic nephropathy
- Status last verified
- Sep 2019
- First submitted
- 3 Sep 2019
- Last updated
- 10 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29371774Adamska 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.
PubMed 28579156
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcription Factor 7 Like 2 Gene Polymorphism and Advanced Glycation End Products as Risk Factors for Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT04084886
- Acronym / sponsor ID
- TCF7L2 in Diabetic nephropathy
- Conditions
- Diabetic Nephropathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To study genotypic distribution of the TCF7L2 gene polymorphism in Diabetic nephropathy.
- To assess level of AGEs and Insulin in patients with Diabetic nephropathy.
- To study correlation between polymorphism of the TCF7L2 gene, AGEs, Insulin and clinical characteristics in patients with diabetic nephropathy
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- diabetic nephropathy
- clinical diagnosis of prediabetes
- Type 2 diabetic patients
Key exclusion criteria (3 listed)
- cardiovascular disease
- diabetic neuropathy
- diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Background: PubMed 29371774Gawandi 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.
- Background: PubMed 28579156Adamska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Nephropathies, run by Assiut University.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ghadeer Abdelrazzak (01011676458, ghadeer.razzak111@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
value of the odds ratio associated with the relationship between a polymorphism TCF7L2 gene and the occurrence of diabetic nephropathy (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04084886, which also lists 2 linked publications.
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 10 Sep 2019.