Unique ID issued by UMIN | UMIN000016219 |
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Receipt number | R000018820 |
Scientific Title | The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency |
Date of disclosure of the study information | 2015/01/15 |
Last modified on | 2021/07/21 10:47:45 |
The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
The dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Japan |
Secondary adrenal insufficiency
Endocrinology and Metabolism |
Others
NO
To investigate the dose fluctuation effect of glucocorticoid on the quality of life (QOL) and metabolism in patients with secondary adrenal insufficiency
Safety
QOL, Blood pressure, glucose metabolism, lipid metabolism, bone metabolism
Interventional
Cross-over
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
3
Treatment
Medicine |
Duration 1 month
Subject secondary adrenal insufficiency
glucocorticoid treatment hydrocortisone 10 mg/day
Duration 1 month
Subject secondary adrenal insufficiency
glucocorticoid treatment hydrocortisone 20 mg/day
Duration 1 month
Subject secondary adrenal insufficiency
glucocorticoid treatment hydrocortisone 30 mg/day
20 | years-old | <= |
80 | years-old | >= |
Male and Female
The secondary adrenal insufficiency patient who needs glucocorticoid treatment
Patient who has severe heart failure (NYHA grade 3 or more)
Patient whose serum bilirubin is more than 2.0 mg/dL
Patient whose serum AST or ALT concentration is more than 100 IU/mL
Patient who has malignancy
Patient who has received glucocoriticoids therapy for another diseases
Patient who is unsuitable for this study (Judged by a doctor)
40
1st name | Michio |
Middle name | |
Last name | Otsuki |
Osaka University Graduate School of Medicine
Department of Metabolic Medicine
565-0871
2-2 Yamada-oka, Suita, Osaka, Japan
06-6879-3732
otsuki@endmet.med.osaka-u.ac.jp
1st name | Michio |
Middle name | |
Last name | Otsuki |
Osaka University Graduate School of Medicine
Department of Metabolic Medicine
565-0871
2-2 Yamada-oka, Suita, Osaka, Japan
06-6879-3732
otsuki@endmet.med.osaka-u.ac.jp
Osaka University Graduate School of Medicine
Department of Metabolic Medicine
Osaka University Graduate School of Medicine
Department of Metabolic Medicine
Japanese Governmental office
the Human Ethics Committee of Osaka University Hospital
2-2 Yamadaoka, Suita, Osaka
06-6210-8296
inri@hp-crc.med.osaka-u.ac.jp
NO
2015 | Year | 01 | Month | 15 | Day |
http://www.med.osaka-u.ac.jp/pub/endmet/www/home/
Published
https://www.ncbi.nlm.nih.gov/pubmed/31290981
21
Serum levels of adiponectin and HDL-C correlated significantly with peak cortisol levels after ITT. Serum adiponectin and HDL-C levels were significantly lower in patients with SAI than non-SAI. Serum levels of adiponectin and HDL-C increased in a hydrocortisone dose-dependent manner.
2021 | Year | 07 | Month | 21 | Day |
Secondary adrenal insufficiency patients
We recruited the patients with secondary adrenal insufficiency who had received glucocorticoid replacement therapy between 2013 and 2015 at our department.
There was no adverse event in this study
We analyzed the relationship between serum cortisol levels during ITT and serum adiponectin levels and the lipid profile. Serum adiponectin levels and lipid profile were measured after hydrocortisone replacement therapy at a dose of 10, 20, or 30 mg/d for 4 weeks per term for three term
Completed
2013 | Year | 10 | Month | 25 | Day |
2013 | Year | 10 | Month | 25 | Day |
2014 | Year | 01 | Month | 01 | Day |
2016 | Year | 03 | Month | 31 | Day |
2015 | Year | 01 | Month | 15 | Day |
2021 | Year | 07 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018820
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