Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/04/2009
Date assigned
13/05/2009
Last edited
18/06/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Atkin

ORCID ID

Contact details

HS Brocklehurst Building
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2RW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R0783

Study information

Scientific title

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

Acronym

BV NASH-T2DM

Study hypothesis

Patients with Non-alcoholic Fatty Liver Disease (NAFLD) have at least as great intra-individual variance of insulin resistance measured using the homeostasis model assessment (HOMA-IR) as those with the paradigm of insulin resistance; Type 2 Diabetes.

Ethics approval

Hull and East Riding Research Ethics Committee, approved on 13/03/2009 (ref: LREC 09/H1304/2).

Study design

Observational prospective cross-sectional study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Non-alcoholic fatty liver disease and type 2 diabetes

Intervention

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 blood samples taken to determine the biological variation of insulin resistance and clotting structure and function and on one occasion endothelial function will be measured using Endo-PAT2000® in the 2 groups - NASH/NAFLD and type 2 diabetes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

14/04/2009

Overall trial end date

30/09/2010

Reason abandoned

Participant recruitment issue

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

14/04/2009

Recruitment end date

30/09/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

HS Brocklehurst Building
Hull
HU3 2RW
United Kingdom

Sponsor information

Organisation

Hull and East Yorkshire Hospitals NHS Trust (UK)

Sponsor details

Daisy Building
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom

Sponsor type

Government

Website

http://www.hey.nhs.uk

Funders

Funder type

University/education

Funder name

Diabetes Endowment Fund, University of Hull (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes