Condition category
Nutritional, Metabolic, Endocrine
Date applied
21/06/2011
Date assigned
21/06/2011
Last edited
21/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sarah Steven

ORCID ID

Contact details

Institute for Ageing and Health
Campus for Ageing and Vitality
Newcastle upon Tyne
NE4 5PL
United Kingdom

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 measures

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

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

http://www.newcastle-hospitals.org.uk/

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

foundation

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26628414

Publication citations

Additional files

Editorial Notes

21/06/2016: Publication reference added. 18/12/2015: No publications found on PubMed.