A open label, randomized, controled trial to assess the usefulness of telmisartan in patients with type 2 diabetes, obesity, and NAFLD.

A open label, randomized, controled trial to assess the usefulness of telmisartan in patients with type 2 diabetes, obesity, and NAFLD. - Matsuyama Shimin Hospital, Hypertension therapy for patients with type2 diabetes, obesity and NAFLD. (MADONNA study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002641

Enrollment

Registered

2009-10-21

Start date

2009-10-01

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 mellitus

Interventions

(Telmisartan group) Patients under treatment with telmisartan (40mg/day) are switched from valsartan (80mg/day) to telmisartan at the dose of 40mg/day for 6months. (Valsartan group) Patients under t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients who have been under treatment with valsartan for hypertension for more than 3 months. 2) Patients with more than 100cm2 of visceral fat. 3) Patients with an HbA1c level under 8%.

Exclusion criteria

Exclusion criteria: 1) Patients whose fatty liver is difficult to evaluate. (A heavy drinker, other liver diseases, etc.) 2) Patients requiring hospitalization to attain glycemic control. 3) Patients judged inadequate to participate in this study by their physician.

Design outcomes

Primary

Measure	Time frame
Content of visceral fat and fatty liver	—

Secondary

Measure	Time frame
HbA1c, fasting glucose, fasting CPR, ABI/PWV, body weight, blood pressure	—

Countries

Japan

Contacts

Public ContactTETSUJI NIIYA

MATSUYAMA SHIMIN HOSPITAL Internal medicine

t.niiya@matsuyama-shimin-hsp.or.jp089-943-1151

Outcome results

None listed

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