Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6722
Study information
Scientific title
Effect of change in pancreas and liver fat content upon beta cell function and hepatic insulin action during weight loss in type 2 diabetes: a non-randomised interventional treatment trial
Acronym
DRN 328 Pancreatic Fat Study
Study hypothesis
The aim of this study is to determine the metabolic effects of decreasing excess fat in the liver and pancreas in patients with type 2 diabetes. During an 8-week hypocaloric diet, the study will define the time course of change in response to glucose-induced insulin secretion in relation to change in pancreatic fat content and will define the time course of change in liver insulin sensitivity in relation to change in liver fat content.
Ethics approval
Newcastle upon Tyne and North Tyneside 2 Ethics Committee, 15/06/2009, ref: 09/H0907
Study design
Non-randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Topic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Both, Not Assigned; Disease: Diabetic Control, Metabolic, Obesity
Intervention
The study involves an 8-week period of very low calorie diet (800 cal per day) using liquid based-formula diet (Optifast®) to induce weight loss. In addition to the three sachets of Optifast® per day, participants are asked to eat 240 g of non-starchy vegetables per day and drink at least 2 litres of water or calorie-free beverages per day. During the intervention period, participants are monitored on weekly to fornightly basis by members of the research team which includes a specialist dietician.
Follow Up Length: 3 months
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Liver fat content
2. Pancreatic fat content
3. Hepatic insulin sensitivity
4. Glucose-induced insulin secretion
Each of the above is measured at baseline, week 1, week 4 and week 8.
Secondary outcome measures
Glucose control
Overall trial start date
01/10/2009
Overall trial end date
01/05/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
For type 2 diabetes volunteers:
1. Duration of diabetes up to 2 years
2. Aged between 25 - 65 years, either sex
3. Body mass index (BMI) of 30 - 40 kg/m^2 with stable body weight for preceeding 3 months
4. HbA1c between 6.2 and 9.0%
5. On treatment with diet alone or diet plus metformin
For healthy controls:
1. Normal glucose tolerance plasma fasting triglyceride less than 1.8 mmol/l
2. No family history of type 2 diabetes
3. Matching BMI and age
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 22; UK Sample Size: 22
Participant exclusion criteria
1. Kidney dysfunction (serum creatinine greater than 150 micromol/l)
2. Liver dysfunction (serum alanine aminotransferase [ALT] greater than 2.5 upper limit normal)
3. Contraindications to magnetic resonance imaging (MRI) (metal implants and claustrophobia)
4. Consumption of greater than 14 units of alcohol per week
5. Treatment with sulphonylureas, thiazolidinediones, steroids or beta-blockers
Recruitment start date
01/10/2009
Recruitment end date
01/05/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Musculoskeletal Research Group
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Sponsor details
Northern Centre for Cancer Care
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Diabetes UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
Basic results (scientific)
Publication list