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The effectiveness of Cholestimide on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial

The effectiveness of Cholestimide on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial - The effectiveness of Cholestimide on dyslipidemia with visceral fat accumulation in patients with type 2 diabetes. A randomized parallel crossover trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011218
Enrollment
30
Registered
2013-07-18
Start date
2008-05-01
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

Type 2 Diabetes, Dyslipidemia

Interventions

Administration of Cholestimide 3g/day add on to statin for the first 24 weeks, then withdrawal of Cholestimide for the next 24 weeks Administration of statin for the first 24 weeks, then add Cholestim

Sponsors

Tokyo Women's Medical University, Diabetes Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients whose body mass index(BMI) is above 25, Visceral fat area is above 100cm2, andHbA1c(NGSP) is above 6.5% Patients who have dyslipidemia and administered by Atorvastatin , Pitavastatin or Rosuvastation at least for 2 months, and LDL-cholesterol is above 90 mg/dl

Exclusion criteria

Exclusion criteria: Patients with complete biliary obstruction Patients with hypersensitivity to cholestimide or past history of ileus. Patients with poor control of constipation Patients who take warfarin, tetracycline, Phenobarbital, thyroid gland preparation, digitalis Patients with unstable proliferative diabetic retinopathy Patients whose stage of diabetic nephropathy is above stage 4 Patients who have active infection or are under treatment of malignancy Patients who have macroangiopathy Patients who are considered to be inadequate to participate in this study.

Design outcomes

Secondary

MeasureTime frame
1. Resting energy expenditure, Respiratory quotient 2. HbA1c, blood glucose, Insulin secretion 3.lipid metabolism 4.oxidative stress

Primary

MeasureTime frame
Visceral fat area

Countries

Japan

Contacts

Public ContactRisa Ide

Tokyo Women's Medical University Diabetes Center

fujimaki@dmc.twmu.ac.jp03-3353-8111

Outcome results

None listed

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