Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10274
Study information
Scientific title
Evaluation of pancreas composition and function during return to normal glucose tolerance in type 2 diabetes
Acronym
DRN 591
Study hypothesis
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
10/H0906/78
Study design
Randomised interventional and observational treatment case-controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Drug names
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 trial start date
01/02/2011
Overall trial end date
01/08/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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%
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 28; UK Sample Size: 28
Participant 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
Recruitment start date
01/02/2011
Recruitment end date
01/08/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute for Ageing and Health
Newcastle upon Tyne
NE4 5PL
United Kingdom
Sponsor information
Organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Sponsor details
Claremont Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
European Foundation for the Study of Diabetes (Germany)
Alternative name(s)
EFSD
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
Germany
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
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26628414