The biological variation of insulin resistance and cardiovascular risk factors in patients with non-alcoholic fatty liver disease compared to type 2 diabetes
| ISRCTN | ISRCTN22497467 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22497467 |
| Secondary identifying numbers | R0783 |
- Submission date
- 27/04/2009
- Registration date
- 13/05/2009
- Last edited
- 18/06/2013
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stephen Atkin
Scientific
Scientific
HS Brocklehurst Building
Hull Royal Infirmary
Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Study design | Observational prospective cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | BV NASH-T2DM |
| Study objectives | 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(s) | Hull and East Riding Research Ethics Committee, approved on 13/03/2009 (ref: LREC 09/H1304/2). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 14/04/2009 |
| Completion date | 30/09/2010 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 14/04/2009 |
| Date of final enrolment | 30/09/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
HS Brocklehurst Building
Hull
HU3 2RW
United Kingdom
HU3 2RW
United Kingdom
Sponsor information
Hull and East Yorkshire Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Daisy Building
Castle Hill Hospital
Cottingham
HU16 5JQ
England
United Kingdom
| Website | http://www.hey.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01b11x021 |
Funders
Funder type
University/education
Diabetes Endowment Fund, University of Hull (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
