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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN22497467

Enrollment

Registered

2009-05-13

Start date

2009-04-14

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver disease and type 2 diabetes Nutritional, Metabolic, Endocrine Non-insulin-dependent diabetes mellitus

Interventions

18/06/2013: Please note that this trial was stopped in April 2011. Twenty type 2 diabetes patients and 20 NAFLD/NASH patients will be recruited for this study (total n = 40). Over 5 weeks fasting b

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026