The biological variation of insulin resistance and cardiovascular risk factors in patients with non-alcoholic fatty liver disease compared to type 2 diabetes

Completed

• Conditions: on-alcoholic fatty liver disease and type 2 diabetes; Nutritional, Metabolic, Endocrine; Non-insulin-dependent diabetes mellitus

• Registration Number: ISRCTN22497467
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

For both groups:
Both males and females, over age of 16 years

For NAFLD/non-alcoholic steatohepatitis (NASH) group:
1. Patients with confirmed NAFLD/NASH
2. Able to give informed consent
3. Agreeing to consent to inform GP's regarding participation in the study
4. No change in medication for 3 months prior to starting the study

For type 2 diabetes group:
1. Diabetes diagnosed according to World Health Organization (WHO) criteria
2. No change in medication for 3 months prior to starting study

Exclusion Criteria

For NAFLD/NASH group:
1. Patients with concurrent illnesses
2. Patients not wishing to allow disclosure to their GP's
3. Alcohol intake more than 14 units/week for women, 21 units a week for men
4. Diabetic patients
5. Pregnancy or breastfeeding women
6. Smokers

For type 2 diabetes group:
1. Abnormal results from liver function tests (LFTs)
2. Patients with concurrent illnesses
3. Patients not wishing to allow disclosure to their GP's
4. Alcohol intake more than 14 units/week for women, 21 units a week for men
5. Pregnancy or breastfeeding women
6. Smokers

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the biological variation of insulin resistance measured by HOMA in patients with NAFLD compared to type 2 diabetes.

Secondary Outcome Measures

Name	Time	Method
1. To show statistically significant greater intra-individual variance of insulin resistance measured by HOMA in patients with NASH<br>2. To determine the level of endothelial dysfunction in subjects with NASH compared to NAFLD compared to type 2 diabetes<br>3. To determine the fibrin clot structure and function in subjects with NAFLD/NASH compared to type 2 diabetes