Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05143918
Other study ID # quality of life
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 31, 2021
Est. completion date December 30, 2023

Study information

Verified date December 2021
Source Assiut University
Contact Noha F Radwan
Phone 01007312012
Email nohafathy154731994@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Assessment of quality of life among hypothyroid patients in Assiut University Hospital


Description:

Hypothyroidism is an underactive thyroid gland. Hypothyroidism means that the thyroid gland can't make enough thyroid hormone to keep the body running normally. People are hypothyroid if they have too little thyroid hormone in the blood. Common causes are Iodine deficiency, autoimmune disease, such as Hashimoto's thyroiditis, surgical removal of the thyroid, and radiation treatment. There are three types of hypothyroidism: primary, secondary and tertiary. Primary hypothyroidism results from a low level of thyroid hormone due to destruction of the thyroid gland. This condition results in increased secretion and elevation of serum thyroid-stimulating hormone (TSH) levels. If the structure of the gland remains normal, dysfunction can be caused by decreased TSH secretion from the pituitary; this Is called secondary hypothyroidism. In tertiary hypothyroidism, a decrease in thyroid hormone arises from inadequate secretion of thyrotropin-releasing hormone (TRH) from the hypothalamus. It is not always possible to differentiate between secondary and tertiary hypothyroidism, and they are often collectively referred to as central hypothyroidism. About 99%ofhypothyroidism cases are primary hypothyroidism. Hypothyroidism is common throughout the world. In iodine-sufficient countries, the prevalence of hypothyroidism ranges from 1% to 2%. rising to 7% in individuals aged between 85 and 89 years. In the absence of age-specific reference ranges for TSH, an ageing population is likely to result in a higher prevalence of hypothyroidism. Hypothyroidism is approximately ten times more prevalent in women than men10. the awareness of hypothyroidism has increased gradually, as has rate of initiation of levothyroxine substitution. Symptoms usually develop slowly and the patient may not realise to have a medical problem for several years. Common symptoms include: tiredness, being sensitive to cold, weight gain, constipation, depression, slow movements and thoughts, muscle aches and weakness, muscle cramps, dry and scaly skin, brittle hair and nails, loss of libido (sex drive), pain, numbness and a tingling sensation in the hand and fingers (carpal tunnel syndrome),irregular periods or heavy periods. Health-related quality of life (HRQL) is a subjective assessment of the effects of disease and its treatment on the physical, social, psychological, and somatic dimensions of a patient's life. Thus, HRQL is considered an important supplementary outcome measure in the management of different conditions. Thyroid hormones are important for the body's total energy metabolism and the neuroendocrine function. Hence, it seems apparent that a dysfunction of the thyroid hormone secretion should have a major influence on the total capacity of the body, both physically and mentally. Increasing attention is being paid to assessing HRQL among patients with thyroid disorders, and previous studies have revealed that HRQL is frequently affected in patients with hypothyroidism. Up to our knowledge, no previous study explored the quality of life and its correlates among Egyptian hypothyroidism patients. The current study aims to assess the quality of life and its predictor among hypothyroidism in Assiut University Hospital


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 176
Est. completion date December 30, 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: 1. age ranges will be 18 - 60 years 2. both genders 3. previously confirmed diagnosed Exclusion Criteria: - Exclusion criteria: 1. pregnancy 2. other comorbidities (hypertension, diabetes, malignancy,,,etc)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
assessment of quality of life using questionnaire
assessment of quality of life in hypothyroid patients using SF 36 questionnaire

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (4)

Blazewicz A, Wisniewska P, Skórzynska-Dziduszko K. Selected Essential and Toxic Chemical Elements in Hypothyroidism-A Literature Review (2001-2021). Int J Mol Sci. 2021 Sep 20;22(18). pii: 10147. doi: 10.3390/ijms221810147. Review. — View Citation

Mitchell AL, Hegedüs L, Žarkovic M, Hickey JL, Perros P. Patient satisfaction and quality of life in hypothyroidism: An online survey by the british thyroid foundation. Clin Endocrinol (Oxf). 2021 Mar;94(3):513-520. doi: 10.1111/cen.14340. Epub 2020 Dec 1 — View Citation

Shivaprasad C, Rakesh B, Anish K, Annie P, Amit G, Dwarakanath CS. Impairment of Health-related Quality of Life among Indian Patients with Hypothyroidism. Indian J Endocrinol Metab. 2018 May-Jun;22(3):335-338. doi: 10.4103/ijem.IJEM_702_17. — View Citation

Taylor PN, Albrecht D, Scholz A, Gutierrez-Buey G, Lazarus JH, Dayan CM, Okosieme OE. Global epidemiology of hyperthyroidism and hypothyroidism. Nat Rev Endocrinol. 2018 May;14(5):301-316. doi: 10.1038/nrendo.2018.18. Epub 2018 Mar 23. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary predictors of quality of life among hypothyroid patients Using the Short Form (36) Health Survey (SF-36) questionnaire all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100. nearly two year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05975866 - The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato N/A
Not yet recruiting NCT05334771 - Early Detection of Endolymphatic Hydrops in Hypothyroid Patients
Withdrawn NCT01707056 - The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma N/A
Completed NCT00094237 - Subclinical Thyroid Dysfunction and Risk of Myocardial Infarction and Stroke N/A
Recruiting NCT06015620 - Comorbidities Resolution After MGB Surgery and Change in Body Composition
Completed NCT03612908 - TSHβX1 and D2 THR92ALA in Pregnancy
Completed NCT04782856 - Energy Metabolism in Thyroidectomized Patients Phase 2
Completed NCT01921452 - Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit Phase 4
Completed NCT01197183 - Observational Study With Prospective and/or Retrospective Follow-up, Without Modifying Patient Treatment and Follow-up Practices for the Initial Treatment of Hypothyroidism in France N/A
Recruiting NCT05247476 - Type 2 Deiodinase Gene Polymorphism and the Treatment of Hypothyroidism Caused by Thyroidectomy in Thyroid Cancer Patients. Phase 4
Recruiting NCT03754621 - Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey
Completed NCT02959827 - Iodinated Contrast Agents and Risk of Hypothyroidism in Young Children in the United States
Completed NCT04124705 - A Study of Armour® Thyroid Compared to Synthetic T4 (Levothyroxine) in Previously Hypothyroid Participants Phase 2
Withdrawn NCT02577367 - Mean Percentage of Levothyroxine Dosage Increase in Patients With Hypothyroidism Started on Enteral Feeding Phase 4
Completed NCT04098991 - Improving White Matter Integrity With Thyroid Hormone
Not yet recruiting NCT03257566 - Hypothyroidism in Patients With Type 1 Diabetes N/A
Terminated NCT02567877 - Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?
Completed NCT02280330 - Iodine Status of Preschoolers Given Micronutrient Powder for 6 Months Phase 4
Completed NCT00403390 - Generic vs. Name-Brand Levothyroxine N/A
Not yet recruiting NCT06096454 - Effect of Life Style Modification and Metformin on Hypothyroidism With Insulin Resistance Phase 4

External Links