Evaluation of pancreas composition and function during return to normal glucose tolerance in type 2 diabetes
| ISRCTN | ISRCTN11969319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11969319 |
| Secondary identifying numbers | 10274 |
- Submission date
- 21/06/2011
- Registration date
- 21/06/2011
- Last edited
- 21/06/2016
- 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 Sarah Steven
Scientific
Scientific
Institute for Ageing and Health
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom
Study information
| Study design | Randomised interventional and observational treatment case-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Evaluation of pancreas composition and function during return to normal glucose tolerance in type 2 diabetes |
| Study acronym | DRN 591 |
| Study objectives | The overall objective is to elucidate the pathophysiology of type 2 diabetes by defining the contribution of change in beta cell function and insulin sensitivity to the return to normal glucose homeostasis during definitive therapeutic intervention. The compelling in vitro and in vivo animal data for a direct adverse effect of fatty acid exposure on beta cell function and hepatic insulin sensitivity will be tested in vivo in people with type 2 diabetes by use of a newly devised magnetic resonance technique. The specific hypothesis will be tested that the early effect of bariatric surgery in normalising blood glucose in type 2 diabetes is brought about by the same mechanistic changes as seen during hypocaloric dieting. |
| Ethics approval(s) | 10/H0906/78 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network, Metabolic and Endocrine; Subtopic: Type 2, Metabolic and Endocrine (all Subtopics); Disease: Metabolic |
| Intervention | 1. Subjects with and without type 2 diabetes will be investigated before and after gastric bypass surgery 2. Very low calorie diet (VLCD) 3. Subjects with T2DM will be randomised into 'surgery only' or 'VLCD+surgery' groups |
| Intervention type | Mixed |
| Primary outcome measure | First phase insulin response at baseline, 1 week after intervention and 8 weeks after surgery |
| Secondary outcome measures | 1. Liver fat and hepatic insulin sensitivity at baseline, 1 week after intervention and 8 weeks after surgery 2. The treatment induced changes in pancreatic fat content at baseline, 1 week after intervention and 8 weeks after surgery |
| Overall study start date | 01/02/2011 |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 28; UK Sample Size: 28 |
| Key inclusion criteria | 1. Type 2 diabetes duration less than 15 years 2. On treatment with diet alone or diet plus oral agents 3. BMI 35-45m/kg2 4. Listed for gastric bypass surgery 5. HbA1c < 10% |
| Key exclusion criteria | 1. Waist circumference >150cm 2. Kidney dysfunction (serum creatinine >150 µmol/l) 3. Liver dysfunction (serum ALT > 2.5 times the upper limit of normal) 4. Contraindications to MRI (metal implants and claustrophobia) 5. Alcohol consumption >14 units per week 6. Treatment with thiazolidinediones, insulin, GLP1 analogues or steroids 7. History of bowel surgery or inflammatory bowel disease |
| Date of first enrolment | 01/02/2011 |
| Date of final enrolment | 01/08/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute for Ageing and Health
Newcastle upon Tyne
NE4 5PL
United Kingdom
NE4 5PL
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust
Hospital/treatment centre
Hospital/treatment centre
Claremont Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Research organisation
European Foundation for the Study of Diabetes (Germany)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- The European Association for the Study of Diabetes, EFSD
- Location
- Germany
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No |
Editorial Notes
21/06/2016: Publication reference added.
18/12/2015: No publications found on PubMed.
