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Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial

Effects of DPP4 inhibitor, sitagliptin or Sulfonylurea on intrahepatic adipose mass and lipid metabolism in patients with type 2 diabetes accompanied by fatty liver : a prospective randomized, open-label trial - Sitagliptin Effect on fatty liver and Lipid Metabolism study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013356
Enrollment
60
Registered
2014-03-06
Start date
2014-12-31
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

Interventions

sitagliptin administration group Glimepiride administration group

Sponsors

St.Marianna University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Inadequately controlled type 2 diabetic patients who are not taking antidiabetic agent other than metformin for more than 2 month. Patients whose HbA1c ranges from 6.9% to 9.4%. 2)Patients who had Fatty liver, or Patients whose IHL(intrahepatic lipid content)is more than 10% on 1H-MRS, or Patients who had metabolic syndrome fulfilled the diagnostic criteria, or Patients whose BMI is more than 25. 3)Patients who have been received diabetes treatment for more than 6 months. 4)over 20 years age 5)Out patient 6)Gender is not restricted. 7)Patient understands study procedures and agrees to participate in the study by giving written informed consent prior to the study start.

Exclusion criteria

Exclusion criteria: 1)Patients who had diabetic ketosis, or diabetic pre-coma and coma within 6 months of the study entry. 2)Patients with severe infections, before or after operation, or with serious trauma. 3)Patients with pregnancy, possibility of pregnancy or having a breast feeding. 4)Patients with renal insufficiency (serum creatinine = and > 1.5 mg/dl) 5)Patients who received insulin therapy. 6)Patients who administered antihyperlipidemic agent other than Metformin for observation period. 7)Patients who had a history of hypersensitive reaction to DPP-4 inhibitor. 8)Patients whom the attending doctor estimated to be ineligible according to the medical rationale.

Design outcomes

Primary

MeasureTime frame
amount of Intrahepatic adipose mass and visceral fat(MRI,DEXA)

Countries

Japan

Contacts

Public ContactHiroyuki Kato

St.Marianna University School of Medicine Hospital Division of Endocrinology and Metabolism

y2tanaka@marianna-u.ac.jp044-977-8111

Outcome results

None listed

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