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Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy

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ClinicalTrials.gov Identifier: NCT03178253
Recruitment Status : Unknown
Verified June 2017 by maria hamdy, Assiut University.
Recruitment status was:  Enrolling by invitation
First Posted : June 6, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
maria hamdy, Assiut University

Study Description
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Brief 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.


Condition or disease
Hypothyroidism in Diabetes

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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy
Estimated Study Start Date : June 30, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : June 30, 2018

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Groups and Cohorts
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Group/Cohort
3


Outcome Measures
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Primary Outcome Measures :
  1. percentage of hypothyroidism in patients of type 2 diabetes with diabetic nephropathy [ Time Frame: one year ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all diabetic patients
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178253


Locations
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Egypt
Maria Hamdy
Assuit, Egypt
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: maria hamdy, Assiut University
ClinicalTrials.gov Identifier: NCT03178253    
Other Study ID Numbers: assuit1991
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetic Nephropathies
Diabetes Mellitus
Hypothyroidism
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Diabetes Complications
Thyroid Diseases