Antidiabetic Effects on Intrahepatic Fat

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT03068065
Phase
PHASE4
Status
Completed

Conditions

  • Non-Alcoholic Fatty Liver Disease
  • Type2 Diabetes

Eligibility Criteria

Sex
ALL
Age
17 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
    the dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study
  • Metformin — DRUG
    the dosage of metformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study
  • Gliclazide — DRUG
    the initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of \<7.0 mmol/L

Study Details

This was a 24-week single-center, open-label, parallel controlled group comparing gliclazide, liraglutide, and metformin effects on diabetes with nonalcoholic fatty liver disease.

Key Dates

Start date
May 31, 2014
Status verified
Feb 2017
Primary completion
Nov 30, 2014
Completion
Oct 31, 2015

Study Design

Enrollment
87 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Liraglutide
    the dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study
  • Active Comparator: Metformin
    the dosage of merformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study
  • Active Comparator: Gliclazide
    the initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of \<7.0 mmol/L

Primary Outcome Measure

Intrahepatic fat [ Time Frame: -7±3days; 168±3days ]

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