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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03154398
Other study ID # Assiut1991
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date December 1, 2019

Study information

Verified date February 2021
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (USA) on diabetes . So, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . The association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. With insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other . Diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. Diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis. As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may increase susceptibility to hypoglycemia thus complicating diabetes management so Severe diabetic complications where noted in patients with sub- clinical hypothyroidism . Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy.


Description:

Recognition and treatment of thyroid dysfunction in diabetic patients will benefit glycemic control and improve general well-being Diabetic nephropathy, a major microvascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. It results from interactions between hemodynamic and metabolic factors.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Type 2 diabetes mellitus and with diabetic nephropathy. Exclusion Criteria: - 1) Insulin dependent diabetes 2) Patients with: - Gestational diabetes mellitus. - Steroid induced Diabetes. 3) Thyroid disease

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Egypt Assuit University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary the percentage of patients progress to advanced diabetic nephropathy one year