Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT01486667
Status:
UNKNOWN
Last Update Posted:
2011-12-08
First Post:
2011-12-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'lastUpdateSubmitDate': '2011-12-06', 'studyFirstSubmitDate': '2011-12-03', 'studyFirstSubmitQcDate': '2011-12-05', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score.', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Effect of the treatment of subclinical hypothyroidism on the lipid profile in patient with dyslipidemia and on hs-CRP', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['focus of study instead'], 'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': "Obstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.\n\nSubclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects; however, the effect of levothyroxine is controversial.\n\nThis project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.It will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.", 'detailedDescription': "Research Problem:\n\nObstructive sleep apnea (OSA) and hypothyroidism are both commonly found in clinical practice, and share a number of symptoms and clinical features. It has been shown that hypothyroid subjects are at high risk of developing sleep disorder breathing and OSA, and adequate thyroxine treatment may reduce the sleep disordered breathing.. However, the time-course and effect of treating subclinical hypothyroidism in OSA patients on the respiratory events during sleep is not known.\n\nSubclinical hypothyroidism is associated with an increased risk of coronary heart disease (CHD). Dyslipidemia is a known complications of subclinical hypothyroidism (2)and the effect of thyroxine treatment on lipid profile is controversial . Some reports suggested higher serum high-sensitivity C-reactive protein (hs-CRP), than healthy subjects ; however, the effect of levothyroxine is controversial .\n\nResearch Significance:\n\nThis project will help us to know if the treatment of subclinical hypothyroidism will improve the symptoms and reduce the progression of OSA, which may improve patients' quality of life by reducing the complication of OSA (hypertension, , depression, Cardiovascular diseases, etc.) or may even reduce mortality.\n\nIt will help us to know the effect of subclinical hypothyroidism treatment on of lipid profiles and hs-CRP.\n\nResearch Objectives:\n\nPrimary objective:\n\n• Effect of the treatment of subclinical hypothyroidism on the apnea hypopnea index (AHI) score.\n\nSecondary objectives:\n\n* Effect of the treatment of subclinical hypothyroidism on the lipid profile in patient with dyslipidemia.\n* Effect of the treatment of subclinical hypothyroidism on hs-CRP\n\nResearch Methodology:\n\nPatients with subclinical hypothyroidism will undergo first Polysomnography (PSG) (night 0) and laboratory investigations including lipid profiles and hc-CRP and then they will be enrolled and randomly assigned to receive either levothyroxine replacement therapy or identical placebo tablets in a blinded manner. The starting dose will be 25 mcg/day and the dose will be adjusted every 6 weeks to target TSH level between (0.25 -2.5 IU/mL). We will keep all patients on replacement dose for duration of 24 weeks. PSG will be performed twice only for OSA patient, after 12 weeks (night 1) and after 24 weeks (night 2). Lipid profile and hs-CRP will be done at the end of 24th weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\>18 years old\n* With Subclinical hypothyroidism defined as serum TSH concentration above 5.0 IU/mL when serum FT4 level is within the reference range\n* With OSA defined as mild OSA: AHI 5 to 15/h; moderate OSA:AHI 15 to 30/h; and severe OSA: AHI greater than 30/h (30) will be enrolled.\n* With confirmed sustained subclinical hypothyroidism, thus excluding patients with a temporary condition such as that in recovery from a non-thyroidal illness, measurement of TSH and FT4 will be conducted within four weeks before randomization.\n\nExclusion Criteria:\n\n* Current treatment with Levothyroxine and lipid lowering medications or within two months before randomization.\n* Conditions known to cause dyslipidemia e.g. uncontrolled diabetes mellitus (HbA1c \\>9), alcoholism and some medication use e.g. Estrogens. Glucocorticoids, Retinoids or Interferons.\n* Conditions indicating levothyroxine treatment (34); including TSH levels more than 10 mU/l, clear symptoms or signs associated with thyroid failure and not related to OSA . e.g. goiter.\n* State of pregnancy, Breast feeding or allergy to levothyroxine.'}, 'identificationModule': {'nctId': 'NCT01486667', 'briefTitle': 'Thyroxin Treatment in Sub Clinical Hypothyroidism, on the Apnea Hypopnea Index Score, Lipids and Highly Sensitive CRP', 'organization': {'class': 'OTHER', 'fullName': 'King Saud University'}, 'officialTitle': 'Effect of Thyroxin Treatment in Sub Clinical Hypothyroidism Patients, on the Apnea Hypopnea Index Score, Lipid Profiles and Highly Sensitive CRP : A Randomized Double Blind Controlled Trial', 'orgStudyIdInfo': {'id': 'E-11-465'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'sugar pill', 'interventionNames': ['Drug: sugar pill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Levothyroxine', 'description': 'Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of levothyroxine will subsequently be individualized for each patients. Serum levels of TSH and FT4 will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol.', 'interventionNames': ['Drug: levothyroxine']}], 'interventions': [{'name': 'levothyroxine', 'type': 'DRUG', 'description': 'Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of levothyroxine will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of levothyroxine. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol.', 'armGroupLabels': ['Levothyroxine']}, {'name': 'sugar pill', 'type': 'DRUG', 'description': 'Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of drug will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of medication. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol.', 'armGroupLabels': ['sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11472', 'city': 'Riyadh', 'state': 'Riyadh Region', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Anwar A Jammah, MD, FACP,FRCPC', 'role': 'CONTACT', 'email': 'drjammah@gmail.com', 'phone': '(+966 1) 467-11784; 467-9179'}, {'name': 'Reda AboAlsoud, MD', 'role': 'CONTACT', 'email': 'usdc@ksu.edu.sa', 'phone': '+966509662742'}, {'name': 'Ahmed S BaHammam, FRCP, FCCP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Anwar A Jammah, MD, FACP, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Muneer S Muhammad', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Sleep Disorders Center', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Anwar A Jammah, MD, FACP, FRCP', 'role': 'CONTACT', 'email': 'drjammah@gmail.com', 'phone': '(+966) 1 467-7555'}, {'name': 'Reda A AboAlsaud, MD', 'role': 'CONTACT', 'email': 'rectoroffice(@)ksu.edu.sa', 'phone': '+966509662742'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSISTANT PROFESSOR & CONSULTANT IN MEDICINE, ENDOCRINOLOGY, DIABETES & THYROID ONCOLOGY', 'investigatorFullName': 'Anwar Ali Jammah', 'investigatorAffiliation': 'King Saud University'}}}}