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Status unknownNCT03178253Updated Jun 7, 2017

Hypothyroidism in Patients With Type 2 Diabetes With Early Diabetic Nephropathy

An observational study in Hypothyroidism in Diabetes, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-06-07.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
40 Years to 70 Years
Sex
All
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Study 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.

Read the 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 .

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Conditions studied

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In context

Diabetic Nephropathies

534 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.

This study's planned enrollment of 100 is below the median of 154 across 142 observational studies indexed under Diabetic Nephropathies.

Browse Diabetic Nephropathies studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

all diabetic patients

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 3
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What researchers measure

Primary outcomes

  1. percentage of hypothyroidism in patients of type 2 diabetes with diabetic nephropathy

    Time frame: one year

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Study locations

1 site
  • Maria Hamdy
    Assuit, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03178253
Lead sponsor
Assiut University
Responsible party
maria hamdy (Assiut University, Assiut University) — Principal investigator
First posted
Jun 6, 2017
Start date
Jun 30, 2017 (estimated)
Primary completion
Jun 30, 2017 (estimated)
Completion
Jun 30, 2018 (estimated)
Last update
Jun 7, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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