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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000657
Receipt No. R000000787
Scientific Title Hypothyroidism in Hyperlipidemia in Japan
Date of disclosure of the study information 2007/04/01
Last modified on 2010/04/01

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Basic information
Public title Hypothyroidism in Hyperlipidemia in Japan
Acronym Hypothyroidism in Hyperlipidemia
Scientific Title Hypothyroidism in Hyperlipidemia in Japan
Scientific Title:Acronym Hypothyroidism in Hyperlipidemia
Region
Japan

Condition
Condition Hyperlipidemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The first aim of the study is to elucidate the prevalence of hyperlipidemia due to hypothyroidism and/or subclinical hypothyroidism in patients with hyperlipidemia. The second aim of the study is to evaluate the effects of replacement therapy with thyroid hormone (T4) on the serum lipid levels, blood pressure, and body weight.
Basic objectives2 Others
Basic objectives -Others Prevalence
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of hypothyroidism and/or subclinical hypothyroidism in patients with hyperlipidemia
Key secondary outcomes Effects of thyroid hormone replacement on serum lipid levels

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with hyperlipidemia without severe complications and who agreed with the study. Both outpatients and in-patients who fulfilled the following criteria: 1) diagnosis of hypercholesterolemia based upon the diagnostic criteria of the Japan Atherosclerosis Society and 2) over the age of 20 years. Those patients who have been treated under the diagnosis of hypercholesterolemia can also be included.
Key exclusion criteria 1) Patients with known thyroid hormone abnormalities
2) Patients with hyperlipidemia due to known diseases other than the thyroid diseases: nephrotic syndrome, primary biliary cirrhosis, obstructive jaundice, Cushing's syndrome, acromegaly, pheochromocytoma, medicine (diuretics, beta blockers, steroid hormones, contraceptives, cyclosporin), heavy alcohol drinker
3) Pregnancy
4) Patients under steroid hormone treatment
5) Unstable stage of the following diseases; coronary diseases, arrhythmias, valvular diseases, heart failure, cerebrovascular diseases, renal failure, diabetes mellitus with very poor control, neuro-muscular diseases, malignancy
6) Conditions when doctors assume inappropriate to enroll
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Kimura
Organization National Hospital Organization
Nagasaki Medical Center
Division name Medicine
Zip code
Address Nagasaki Prefecture, Ohmura City, Hisahara,2-1001-1
TEL 0957-52-3121
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuhide Naruse
Organization National Hospital Organization, Kyoto Medical Center
Division name Department of Endocrinology, Clinical Research Institute for Endocrine and Metabolic Diseases
Zip code
Address 1-1 Fukakusa-Mukaihatacho, Fushimiku,Kyoto, Japan
TEL 075-641-9164
Homepage URL
Email mnaruse@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization, Kyoto Medical Center
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Nishigunnma,Minamiyokohama,Mie,Tokushima,Kokura,Tenri Yorozu Hospital/
Kanazawa,Mie Chuo,Osaka Minami,Yonago,
Kyushu,Ureshino Medical Center,MisatoKenwa Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2006 Year 10 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 05 Month 01 Day
Date trial data considered complete
2008 Year 07 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information The first aim of the study is to clarify the prevalence of hypothyroidism and subclinical hypothyroidism in patients with hyperlipidemia by the screening with plasma thyroid hormone and TSH. The second aim of the study is to elucidate the effects of replacement therapy on the blood lipid levels, blood pressure, and body weight. Both outpatients and in-patients with hyperlipidemia without severe complications and who gave informed consent of the study are enrolled. Patients fulfilled the following criteria: 1) diagnosis of hypercholesterolemia based upon the diagnostic criteria of the Japan Atherosclerosis Society and 2) over the age of 20 years. Exclusion criteria includes 1) Patients with known thyroid hormone abnormalities, 2) Patients with hyperlipidemia due to known diseases other than the thyroid diseases, 3) Pregnancy, 4) Patients under steroid hormone treatment, 5) Unstable stage of the cardiovascular diseases, 6) Conditions when doctors assume inappropriate to enroll, respectively. Those patients with hypothyroidism including subclinical hypothyroidism are subjected to thyroid hormone replacement therapy. Effects of the treatment were evaluated after 4weeks, 12 weeks, 6 months, and 12 months of treatment. Physical findings, vital sign, biochemical data, and thyroid hormones were investigated.

Management information
Registered date
2007 Year 03 Month 28 Day
Last modified on
2010 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000787

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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