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 |
| Protocol serial number | 6722 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust (UK) |
| Funder | Diabetes UK (UK) |
- 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
Scientific
Musculoskeletal Research Group
4th Floor, Catherine Cookson Building
The Medical School
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional treatment trial |
| Secondary study design | Non randomised controlled trial |
| 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 |
| Study acronym | DRN 328 Pancreatic Fat Study |
| Study objectives | 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(s) | Newcastle upon Tyne and North Tyneside 2 Ethics Committee, 15/06/2009, ref: 09/H0907 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Liver fat content |
| Key secondary outcome measure(s) |
Glucose control |
| Completion date | 01/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 22 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 01/05/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Musculoskeletal Research Group
Newcastle Upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
