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

• Sponsor: Ain Shams University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04178928
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

1. 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.

Condition or Disease	Intervention/Treatment	Phase
Subclinical hypothyroïdism	Drug: Levothyroxine	Phase 1/Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Can Levothyroxine Treatment Reduce the Development of Cardio-metabolic Disorder in Subclinical Hypothyroidism?
• Anticipated Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: Jan 1, 2021
• Anticipated Study Completion Date: Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: Levothyroxine; investigate the effect of replacement therapy with levothyroxine on cardiovascular risk factors in children with SCH.
No Intervention: Group B .pWill not receive treatment.atients with SCH will be subjected to clinical, laboratory and imaging assessment and

Outcome Measures

Primary Outcome Measures

1. : Normalization of TSH. [12 week]

   Normalization of TSH by receive L-T4 treatment at a dose 1 µg/kg/day for 12 weeks. And the dose will be titrated every 4 weeks then check differences in results between baseline assessment and12 weeks after intervention.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

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

2. Patients with BMI>95 percentile.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nashwa Mohamed Abd elwahab, MD candidate, Ain Shams University
• ClinicalTrials.gov Identifier: NCT04178928
• Other Study ID Numbers: Sub clinical hypothyroidism
• First Posted: Nov 26, 2019
• Last Update Posted: Nov 29, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Hypothyroidism

Study Results

No Results Posted as of Nov 29, 2019