Non-alcoholic fatty liver disease (NAFLD) - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University of Oxford

Recruitment countries:

United Kingdom

Health condition studied:

Non-alcoholic Fatty Liver Disease

URL:

Link to the clinical trial website

About the trial

Interventions:

Drug: Metformin
Drug: SGLT2 inhibitor

Key inclusion and exclusion criteria:

• 
  Inclusion Criteria:
  
  Arm 1: SGLT2 inhibitors
  
  - Volunteers with diagnosis of Type 2 Diabetes on oral anti-diabetic therapy at a
  stable dose for =3 months including one of the following:
  
  i. Metformin monotherapy ii. Sulphonylurea monotherapy iii. Metformin and
  Sulphonylurea dual therapy
  
  - All volunteers will be due to start SGLT2 inhibitor therapy for inadequate glycaemic
  control and it will be prescribed according to licensed indications.
  
  Arm 2: metformin
  
  • Insulin resistant treatment naive individuals as defined by fasting insulin and / or
  glucose in top 10th percentile
  
  Both arms:
  
  - Participant is willing and able to give informed consent for participation in the
  study.
  
  - Male or Female, aged between 18 years and 70 years.
  
  - BMI: 25-45 kg/m2
  
  - HbA1C: 42-86mmol/mol
  
  - Normal renal function
  
  Exclusion Criteria:
  
  Arm 1: SGLT2 inhibitors Volunteers taking insulin, glucagon-like peptide 1 analogues,
  thiazolidinediones, or dipeptidyl peptidase IV inhibitors
  
  Arm 2: metformin Volunteers taking insulin, glucagon-like peptide 1 analogues,
  thiazolidinediones, SGLT2 inhibitors, metformin or dipeptidyl peptidase IV inhibitors
  
  Both arms
  
  - Age <18 or >70 years
  
  - Body mass index <25 or >45kg/m2
  
  - A blood haemoglobin <120mg/dL
  
  - History of alcoholism or a greater than recommended alcohol intake (Recommendations >
  21 drinks on average per week in men and > 14 drinks on average per week in women)
  
  - Pregnant or nursing mothers
  
  - History of severe claustrophobia
  
  - Presence of metallic implants, pacemaker
  
  - Haemorrhagic disorders
  
  - Anticoagulant treatment
  
  - History of albumin allergy
  

• Age minimum:  18 Years
• Age maximum:  70 Years
• Gender:  Both

Primary outcomes:

Hepatic steatosis

Secondary outcomes:

% contribution of newly synthesised lipid to circulating triglyceride levels
Global insulin sensitivity
Hepatic insulin sensitivity
Intrabdominal fat

Target sample size:

23

Study type:

Interventional

Study design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Contacts:

• Name:   Jeremy W Tomlinson, MD PhD
• Address: 
• Phone: 
• Email: 
• Affiliation:  University of Oxford

• Name:   Jeremy W Tomlinson, MD PhD
• Address: 
• Phone:  44(0)1865 857359
• Email:  jeremy.tomlinson@ocdem.ox.ac.uk
• Affiliation: 

• Name:   Jeremy W Tomlinson, MD PhD
• Address: 
• Phone:  44(0)1865 857359
• Email:  jeremy.tomlinson@ocdem.ox.ac.uk
• Affiliation: 

Technical details

Scientific title:

SGLT2 Inhibitors and Metformin on Metabolism and Non-Alcoholic SteatoHepatitis

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT02696941

Secondary ID:

11693

Register:

ClinicalTrials.gov

Date of registration:

12/02/2016

Date of first enrollment:

February 2016

Last refreshed:

21 November 2016