UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000657 |
|---|---|
| Receipt number | R000000787 |
| Scientific Title | Hypothyroidism in Hyperlipidemia in Japan |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2010/04/01 13:27:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
mnaruse@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
