Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy

June 6, 2017 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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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 .

Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy. Severe hypothyroidism (biochemically) may be completely asymptomatic. Though our patient had throid stimulating hormone level more than 100 mIU/L, he did not have any symptoms of hypothyroidism.so diagnosis of hypothyroidism depends on laboratory parameters rather than clinical findings Recognition and treatment of hypothyroidism in diabetic patients will benefit glycemic control and improve general well-being ). Diabetic nephropathy, a major micro-vascular 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 (Anticipated)

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
      • Assuit, Egypt
        • Maria Hamdy

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

Non-Probability Sample

Study Population

all diabetic patients

Description

Inclusion Criteria:

  • All patients with Type 2 diabetes mellitus and with diabetic nephropathy.
  • All diabetics irrespective of glucose control.
  • All diabetics irrespective of treatment (oral hypoglycemic drugs/insulin)

Exclusion Criteria:

  • 1) Type 1 diabetes mellitus 2) Patients with:

    • Gestational diabetes mellitus.
    • Pancreatitis.
    • Steroid induced Diabetes.
    • hepatobiliary disease
    • on systemic drug therapy such glucocorticoids and oral contraceptives.

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
3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
percentage of hypothyroidism in patients of type 2 diabetes with 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

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 (Anticipated)

June 30, 2017

Primary Completion (Anticipated)

June 30, 2017

Study Completion (Anticipated)

June 30, 2018

Study Registration Dates

First Submitted

June 3, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (Actual)

June 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2017

Last Update Submitted That Met QC Criteria

June 6, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • assuit1991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Hypothyroidism in Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe