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Antidiabetic Effects on Intrahepatic Fat

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ClinicalTrials.gov Identifier: NCT03068065
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tracking Information
First Submitted Date  ICMJE February 16, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date March 1, 2017
Actual Study Start Date  ICMJE May 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
Intrahepatic fat [ Time Frame: -7±3days; 168±3days ]
intrahepatic fat change from baseline by quantitative ultrasound
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • Liver function [ Time Frame: -7±3days; 28±3days; 84±3days; 168±3days ]
    serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST)
  • Lipid [ Time Frame: -7±3days; 28±3days; 84±3days; 168±3days ]
    total cholesterol (CH), triglyceride (TG), high-density lipoprotein cholesterol (HDL), and low-density lipoprotein cholesterol (LDL)
  • Plasma glucose in standard meal tolerance test [ Time Frame: -7±3days; 168±3days ]
    plasma glucose was measured at 0, 30, 60, and 120 min after ingestion of the meal
  • Plasma insulin in standard meal tolerance test [ Time Frame: -7±3days; 168±3days ]
    plasma insulin was measured at 0, 30, 60, and 120 min after ingestion of the meal
  • Glucose control [ Time Frame: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days ]
    fasting blood glucose (FBG), postprandial blood glucose (PBG)
  • HbA1c [ Time Frame: -7±3days; 84±3days; 168±3days ]
    glycosylated hemoglobin A 1c (HbA1c) was measured by high-performance liquid chromatography
  • Body composition [ Time Frame: -7±3days; 168±3days ]
    fat mass and lean tissue were measured by dual-energy X-ray absorptiometry
  • Weight [ Time Frame: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days ]
    body weight
  • WC [ Time Frame: 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3days; 168±3days ]
    waist circumference
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2017)
Number of Participants with gliclazide, liraglutide or metformin adverse events as a measure of safety and tolerability [ Time Frame: -7±3days; 0±3days; 14±3days; 28±3days; 56±3days; 84±3days; 112±3days; 140±3day;168±3days ]
adverse events caused by the drugs
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Antidiabetic Effects on Intrahepatic Fat
Official Title  ICMJE Comparison of Efficacy of Liraglutide, Metformin and Gliclazide MR on Hepatic Lipid Content in Patients With Type 2 Diabetes (T2DM) and Non-alcoholic Fatty Liver (NAFLD)
Brief Summary 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.
Detailed Description Following enrollment, eligible participants were randomized (1:1:1) using computer-generated random numbers to the metformin (Glucophage, Bristol-Myers Squibb), liraglutide (Victoza, Novo Nordisk), or gliclazide (Diamicron, Servier) groups. All patients were informed about a proper diet and exercise. For the metformin group (n = 31), the dosage 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. For the gliclazide group (n = 31), the initial dosage 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. For the liraglutide group (n = 31), the dosage 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.At the end of the study, data will be collected and analyzed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Alcoholic Fatty Liver Disease
  • Type2 Diabetes
Intervention  ICMJE
  • Drug: 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
    Other Name: Victoza,Novo Nordisk
  • Drug: Metformin
    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
    Other Name: Glucophage,Bristol-Myers Squibb
  • Drug: 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
    Other Name: Diamicron MR,Servier
Study Arms  ICMJE
  • 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
    Intervention: Drug: Liraglutide
  • 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
    Intervention: Drug: Metformin
  • 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
    Intervention: Drug: Gliclazide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2017)
87
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 18-70 years;
  2. Type 2 diabetes mellitus;
  3. Not used antidiabetic drugs within 3 months;
  4. HbA1c(7-10%);
  5. Presence of fatty liver disease (hepatic fat content ≥ 20% by quantitative ultrasonography);
  6. Female subjects:post-menopausal women, take contraceptive measures three months before the test screening and can persist throughout the experimental period;
  7. Body mass index (BMI) 20-35kg/m2, and stable Weight 3 months(less than 10% volatility);
  8. patients signed the informed consent.

Exclusion Criteria:

  1. Used antidiabetic drugs or any other possible hepatic steatosis associated with drugs within the past three months;
  2. Suffering from pancreatitis or other pancreatic diseases or have other similar history;
  3. GLP-1 analogs or sulfonylurea allergy history;
  4. Liver dysfunction (aspartate aminotransferase ≥ 2.5 times of the normalupper limit);
  5. Moderate to severe renal insufficiency (eGFR<60ml/min/1.73m2,calculated according to MDRD);
  6. Female subjects drinking> 14 units / week; male subjects drinking> 21 units/week;
  7. A history of metabolic or autoimmune liver diseases or viral hepatitis diseases;
  8. A history of medullary thyroid carcinoma, multiple endocrine neoplasia 2 or family history;
  9. Congestive heart failure (NYHA grade Ⅲ - Ⅳ grade);
  10. Severe gastrointestinal diseases;
  11. Other serious concomitant diseases;
  12. Pregnant or planning pregnancy;
  13. The researchers believe that the subjects with proliferative retinopathy or macular degeneration need urgentl treatment;
  14. Subjects are using unknown ingredients or non herbal medicine preparations or local medicine, researchers believe that during the test the dose of traditional Chinese medicines can not be adjusted or disabled.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03068065
Other Study ID Numbers  ICMJE ChiCTR-TRC-14004660
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Sponsor  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dalong Zhu, MD,PhD the Affiliated Drum Tower Hospital of Nanjing University
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP