Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
11/08/2014
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 Ee Lin Lim

ORCID ID

Contact details

Musculoskeletal Research Group
4th Floor
Catherine Cookson Building
The Medical School
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6722

Study information

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

Acronym

DRN 328 Pancreatic Fat Study

Study hypothesis

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

Newcastle upon Tyne and North Tyneside 2 Ethics Committee, 15/06/2009, ref: 09/H0907

Study design

Non-randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Liver fat content
2. Pancreatic fat content
3. Hepatic insulin sensitivity
4. Glucose-induced insulin secretion

Each of the above is measured at baseline, week 1, week 4 and week 8.

Secondary outcome measures

Glucose control

Overall trial start date

01/10/2009

Overall trial end date

01/05/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 22; UK Sample Size: 22

Participant 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

Recruitment start date

01/10/2009

Recruitment end date

01/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Musculoskeletal Research Group
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Northern Centre for Cancer Care
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

Sponsor type

Government

Website

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

Funders

Funder type

Charity

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes