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comprehensive analysis of factors which decide hepatic insulin sensitivity in Japanese non-alcoholic fatty liver disease

comprehensive analysis of factors which decide hepatic insulin sensitivity in Japanese non-alcoholic fatty liver disease - comprehensive analysis of factors which decide hepatic insulin sensitivity in Japanese non-alcoholic fatty liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
JPRN
Registry ID
JPRN-UMIN000034902
Enrollment
36
Registered
2018-11-19
Start date
2018-11-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes,Non-alcoholic fatty liver disease

Interventions

None listed

Sponsors

Toho University School of Medicine Division of diabetes,metabolism and endocrinology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.patients who were suspected of having fatty liver (standard criteria; ALT>=31 IU/L) 2.patients who don't take oral hypoglycemic drugs except alpha-GI,SU, glinide

Exclusion criteria

Exclusion criteria: 1.cases whose intra hepatic lipid are 5% and under in 1H-MRS (diagnosis criteria of NAFLD) 2.persons who drink alcohol habitually (men >=30g/day,women >=20g/day) 3.cases whose NAS(NAFLD Activity Score) is 5 point and over in liver biopsy (diagnosis criteria of NASH) (However,2 cases with no liver biopsy can't deny NASH.)

Design outcomes

Primary

MeasureTime frame
The comprehensive analysis which evaluate the association between % suppression of EGP and all assessed indices were performed. (e.g. correlation coefficient of Pearson and Spearman, and single and multiple regression analysis) general items(age,body height,body weight, BMI,body surface area,having diabetes, taking oral hypoglycemic drug) (oral hypoglycemic drug:alpha-GI,SU, glinide) complete blood count(WBC,RBC,Ht,PLT) blood biochemistry(ALT,feritin,high- molecule adiponectin,collagen4,HbA1c, hyaluronic acid,C peptide,cortisol, high-sensitive CRP,urine 8OHdG) hyperinsulinemic-euglycemic clamp (fasting blood glucose,steady state blood glucose,fasting blood insulin,steady state blood insulin,fasting blood insulin times basal endogenous glucose production;basal EGP,steady state glucose infusion rate ;ssGIR,steady state glucose uptake rate ;ssRd,glucose uptake change rate,basal blood free fatty acid,steady state blood free fatty acid,free fatty acid change rate) (basal EGP,ssGIR,ssRd are corrected by lean body weight.) DEXA(fat ratio,lean body weight,whole muscle weight/the square of body height) CT(whole lipid area,visceral fat area, subcutaneous fat area,body circumference) Proton MRS(intramyocellular lipid content,extramyocellular lipid content, intra hepatic lipid) MRI(hepatic fat ratio,liver volume, liver fat volume,lean hepatic volume;all are corrected by body surface area.) QOL content(BDI2,Wellbeing)(research by questionnaire) sleep content(MEQ,pittsburgh,sleep time) (research by questionnaire) exercise content(volume of physical activity,total daily energy expenditure) (measured by medical pedometer) diet (total dietary intake,volume of alcohol intake,carbo,protein and fat intake ratio) (assessed by questionnaire) liver biopsy(fat,intralobular inflammmation,balooning,NAS:NAFLD Activity Score,fibrosis)

Secondary

MeasureTime frame
comprehensive analysis of gene expression (microarray)

Countries

Japan

Contacts

Public ContactHiroyuki Igarashi

Toho University School of Medicine Division of diabetes,metabolism and endocrinology

hiroyuki.igarashi@med.toho-u.ac.jp03-3762-4151(6560)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026