Effect of change in pancreas and liver fat content upon beta cell function and hepatic insulin action during weight loss in type 2 diabetes

ISRCTN ISRCTN57022672
DOI https://doi.org/10.1186/ISRCTN57022672
Secondary identifying numbers 6722
Submission date
23/04/2010
Registration date
23/04/2010
Last edited
22/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ee Lin Lim
Scientific

Musculoskeletal Research Group
4th Floor, Catherine Cookson Building
The Medical School
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Study information

Study designNon-randomised interventional treatment trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific titleEffect 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
Study acronymDRN 328 Pancreatic Fat Study
Study objectivesThe 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(s)Newcastle upon Tyne and North Tyneside 2 Ethics Committee, 15/06/2009, ref: 09/H0907
Health condition(s) or problem(s) studiedTopic: Diabetes Research Network, Primary Care Research Network for England; Subtopic: Both, Not Assigned; Disease: Diabetic Control, Metabolic, Obesity
InterventionThe 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 typeOther
Primary outcome measure1. 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 measuresGlucose control
Overall study start date01/10/2009
Completion date01/05/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 22; UK Sample Size: 22
Key inclusion criteriaFor 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2009
Date of final enrolment01/05/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Musculoskeletal Research Group
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Northern Centre for Cancer Care
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
United Kingdom

Website http://www.newcastle-hospitals.org.uk/
ROR logo "ROR" https://ror.org/05p40t847

Funders

Funder type

Charity

Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
DIABETES UK LIMITED, British Diabetic Association
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2011 Yes No

Editorial Notes

22/02/2019: Publication reference added.