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Can Levothyroxine Treatment Reduce the Development of Cardio-metabolic Disorder in Subclinical Hypothyroidism?

NCT ID: NCT04178928

Last Updated: 2019-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2021-02-28

Brief Summary

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2\. Aim/ Objectives The aim of this study is to evaluate the clinical, laboratory and echocardiographic findings in children with SCH.

To investigate the effect of replacement therapy with levothyroxine on cardiovascular risk factors in children with SCH.

Detailed Description

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Sub-clinical hypothyroidism (SCH) is a form of thyroid dysfunction in which the thyroid-stimulating hormone (TSH) level is high, while serum total/free thyroxine (T4/fT4) is within the normal reference range . SCH is mostly detected accidentally as most of the patients manifest few or no signs of thyroid dysfunction.

The most common causative factor for SCH is chronic autoimmune thyroiditis characterized by high titers of thyroid peroxidase antibodies, thyroglobulin antibodies and rarely TSH receptor blocking antibodies. However, mutations in several proteins involving in TSH action including TSH receptor gene and mutations of dual oxidase 2 (DUOX2), phosphodiesterase 8B and thyroid peroxidase have also been demonstrated as causes of TSH elevation .

SCH might be associated with endothelial dysfunction due to early changes in proatherogenic profiles as there is elevation in plasma levels of total cholesterol (TC) and low-density lipoprotein-cholesterol (LDL-C) in SCH patients , also there is increased risk of hypertension in SCH patients than in euthyroid .

Many studies found that homocysteine concentration appears to be increased in hypothyroidism and decreased in hyperthyroidism, and there is relationship between hyperhomocysteinemia and cardiovascular disease, including increased platelet aggregation, increased coagulation or reduced thrombolysis and endothelial dysfunction .

The acute-phase reactant hs-CRP is known to be a sensitive and non-specific marker for inflammation, tissue damage and infection . Serum hs-CRP measurements are used to determine cardiovascular risk. hs-CRP is regarded as a predictive marker for myocardial infarction, stroke, peripheral artery disease and sudden cardiac death .

The treatment of children with SCH is controversial; and there is not enough evidence that treatment can prevent the risk of developing cardiovascular and metabolic disorders in SCH.

Conditions

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Subclinical hypothyroïdism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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group A

patiWill receive L-T4 treatment at a dose 1 µg/kg/day for 12 weeks. And the dose will be titrated every 4 weeksents with SCH will be subjected to clinical, laboratory and imaging assessment and

Group Type ACTIVE_COMPARATOR

Levothyroxine

Intervention Type DRUG

investigate the effect of replacement therapy with levothyroxine on cardiovascular risk factors in children with SCH.

Group B

.pWill not receive treatment.atients with SCH will be subjected to clinical, laboratory and imaging assessment and

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Levothyroxine

investigate the effect of replacement therapy with levothyroxine on cardiovascular risk factors in children with SCH.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Patients aged from 5-15 years diagnosed with SH (patients with elevated TSH and normal Ft4 on two different measurements 4-6 weeks apart).

Exclusion Criteria

* 1\. Patients with acute or chronic disorders (anemia, infection, diabetes mellitus, malignancy, liver and renal disorder).

2\. Patients with a history of medication that affect thyroid function tests as glucocorticoids, dopamine or dobutamine, amiodarone, lithium, interferons, alemtuzumab.

3\. Patients with BMI\>95 percentile.
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Nashwa Mohamed Abd elwahab

MD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Nashwa MOhamed Abd elwahab, MSCof pediatrics

Role: CONTACT

Phone: 01061487888

Email: [email protected]

Other Identifiers

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Sub clinical hypothyroidism

Identifier Type: -

Identifier Source: org_study_id