Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy. (AssuitU)

February 11, 2021 updated by: maria hamdy, Assiut University

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assuit university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

type 2 diabetes with early nephropthy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
case control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage of patients progress to advanced diabetic nephropathy
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: maria hamdy, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 14, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Assiut1991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

evaluate thyroid dysfunction in patients with diabetes in diabetic nephropathy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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