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 |
| Protocol serial number | 10274 |
| Sponsor | Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | European Foundation for the Study of Diabetes (Germany) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional and observational treatment case-controlled study |
| Secondary study design | Randomised controlled trial |
| Study type | 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(s) |
First phase insulin response at baseline, 1 week after intervention and 8 weeks after surgery |
| Key secondary outcome measure(s) |
1. Liver fat and hepatic insulin sensitivity at baseline, 1 week after intervention and 8 weeks after surgery |
| Completion date | 01/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Institute for Ageing and Health
Newcastle upon Tyne
NE4 5PL
United Kingdom
NE4 5PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/06/2016: Publication reference added.
18/12/2015: No publications found on PubMed.
