Clinical trial NCT03178253: Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy
Official title: Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothyroidism in Diabetes
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all diabetic patients

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.

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 .

Eligibility 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.

Primary outcomes:
measure: percentage of hypothyroidism in patients of type 2 diabetes with diabetic nephropathy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Maria Hamdy
Study officials:
References: