Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy

Hypothyroidism in Diabetes Clinical Trial

Official title:

Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03178253
• Other study ID #: assuit1991
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 3, 2017
• Last updated: June 6, 2017
• Start date: June 30, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• 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.

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 .

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2017
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Nephropathies
• Hypothyroidism
• Hypothyroidism in Diabetes

Locations

Country	Name	City	State
Egypt	Maria Hamdy	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of hypothyroidism in patients of type 2 diabetes with diabetic nephropathy		one year