Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/11/2013
Date assigned
16/12/2013
Last edited
16/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Nonalcoholic fatty liver disease (NAFLD) has attracted considerable attention as a cause of type 2 diabetes. Although no full-scale survey has been conducted in Japan, it is highly expected that the number of patients with NAFLD will increase rapidly with the advancing westernization of eating habits.

Who can participate?
Participants are diabetic males, aged 40-70 years, who are previously untreated for type 2 diabetes (T2DM).

What does the study involve?
Participants will be classified into two groups based on the presence or absence of NAFLD. The participants with NAFLD will be randomly allocated to one of four groups and treated with pioglitazone, metformin or sitagliptin, or a non-antidiabetic drug (non-OAD), for 6 months. In the non-OAD group, participants are provided with dietary and exercise guidance. The participants in the non-NAFLD group will be referred to their respective attending physicians as outpatients for the treatment of diabetes.

What are the possible benefits and risks of participating?
Participants will receive information on their body composition and blood pressure. Possible risks would be adverse effects from antidiabetic drugs. Although computed tomography (CT) poses no significant risk associated with the use of contrast medium, patients may be exposed to some (permissible) dose of radiation.

Where is the study run from?
Second Department of Internal Medicine, Ryukyus University Hospital (Japan).

When is the study starting and how long is it expected to run for?
The study started in August 2010 and will ran until December 2012.

Who is funding the study?
University of the Ryukyus (Japan).

Who is the main contact?
Dr Kouichi Yabiku

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kouichi Yabiku

ORCID ID

Contact details

207 Uehara Nishihara-cho
Nakagami-gun
903-0215
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Mechanisms of action of hypoglycemic drugs in nonalcoholic fatty liver disease (NAFLD): elucidation of its association with 'inflammation'

Acronym

Study hypothesis

Several oral antidiabetic drugs (OADs) will be effective treatments for NAFLD.

Ethics approval

Ethics Committee of the Faculty of Medicine at the University of the Ryukyus, 09/03/2010, No. 122

Study design

Randomized parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Nonalcoholic fatty liver disease, type 2 diabetes

Intervention

Patients are divided into NAFLD and non-NAFLD groups by abdominal ultrasound.

The patients with NAFLD will be then randomly allocated to receive either pioglitazone (30 mg/day), metformin (1 g/day), sitagliptin (50 mg/day) or a non-antidiabetic drug (non-OAD). In the non-OAD group, all subjects are provided with dietary and exercise guidance. Abdominal CT is performed before and after the trial, and changes in NAFLD activity are evaluated.

The patients in the non-NAFLD group are referred to their respective attending physicians as outpatients for the treatment of diabetes, and those in the above monotherapy groups or non-antidiabetic drug group similarly undergo abdominal CT and blood tests before and after the trial.

All subjects are provided with dietary and exercise guidance once a month during the study (6 months).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Differences between baseline and end-of-treatment liver to spleen (L/S) ratios determined by CT and physical findings (blood pressure, body mass index and waist circumference) will be measured in each group.
Blood samples will be obtained to measure concentrations of aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), cholinesterase, fasting plasma glucose, fasting insulin, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, non-esterified fatty acids (NEFA), high-sensitivity C-reactive protein (hsCRP), soluble tumor necrosis factor receptors 1 (sTNFR-1), and 2 (sTNFR-2), high-molecular-weight (HMW) adiponectin, and ferritin.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/08/2010

Overall trial end date

27/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diabetic males aged 40-70 years
2. Previously untreated for type 2 diabetes (T2DM)
3. Body mass index (BMI) >25 kg/m2
4. Glycated hemoglobin (HbA1c) of 6.4-7.9% (National Glycohemoglobin Standardization Program units)
5. Fasting plasma glucose of 126-261 mg/dl

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

800

Participant exclusion criteria

1. Patients with mental disorders, including alcohol dependence, or with such a history
2. Patients with pancreatitis
3. Patients with malignant diseases
4. Patients with viral hepatitis
5. Patients who have participated in any clinical study or trial within 6 months
6. Patients experiencing a weight gain or loss of 1 kg or more within 3 months before the start of the trial
7. Patients deemed ineligible for the trial

Recruitment start date

01/08/2010

Recruitment end date

27/12/2012

Locations

Countries of recruitment

Japan

Trial participating centre

207 Uehara Nishihara-cho
Nakagami-gun
903-0215
Japan

Sponsor information

Organisation

University of Ryukyus (Japan)

Sponsor details

207 Uehara Nishihara-cho
Nakagami-gun
903-0215
Japan

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Ryukyus (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes