Overview

Non-alcoholic Fatty Liver Disease and Its Treatment

Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
0
Participant gender:
All
Summary
Dipeptidyl peptidase-4 inhibitors (DPP-4I), key regulators of the actions of incretin hormones, exert anti-hyperglycemic effects in type 2 diabetes mellitus (T2DM) patients. A major unanswered question concerns the potential ability of DPP-4I to improve intrahepatic lipid (IHL) content in nonalcoholic fatty liver disease (NAFLD) patients. The aim of this study was to evaluate the effects of sitagliptin on IHL in NAFLD patients.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shanghai 10th People's Hospital
Treatments:
Metformin
Sitagliptin Phosphate
Criteria
Inclusion Criteria:

- age 30-70 years old

- fulfillment of the diagnostic criteria for T2DM by WHO in 1999 (HbA1c ranged from 7%
to 10%, FPG < 11 mol/l, 2-hour blood glucose postprandial < 20mmol/l)

- Fulfillment of the diagnostic criteria for NAFLD according to the guidelines of the
Chinese Medical Association in 2010. The IHL content was measured by using 1H-magnetic
resonance spectroscopy (1H-MRS) quantitative detection, and the liver fat content of
the enrolled subjects was more than 5.5%. The subjects included in this study had
either no history of alcohol consumption or their alcohol intake was less than 70
g/week in males and less than 140 g/week in females. Liver transaminase and serum
creatinine were less than two times the upper limit of normal

Exclusion Criteria:

- T2DM complicated with ketoacidosis, hyperosmolarity, acute and chronic infection ●
serious heart, liver, kidney, lung disease, and liver damage

- alcoholic fatty liver

- drug use that influences glucose metabolism such as thiazide diuretics and hormones
within three months

- Hypertension ≥ 180/110 mmHg

- gastrointestinal disease or absorption dysfunction

- recent trauma, surgery, or other conditions resulting in an increased stress response
within the past three months.