Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/12/2013
Date assigned
20/12/2013
Last edited
08/08/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Substantial weight loss achieved following bariatric surgery (e.g. gastric band) can reverse type 2 diabetes (T2D) in 70-80% of patients. However, research has proved that it can also be reversed by a strict energy restricted diet with around 15 kg weight loss. The major clinical question is whether this new knowledge about T2D can now impact its management in GP surgeries. A new approach to routine weight management is clearly required. While previous guidelines have retained a 5-10% weight-loss target, the 2010 SIGN Obesity guideline has set a new weight loss/maintenance target of >15-20% for obese people with diabetes. In routine NHS diabetes care, few people achieve a weight loss of >15kg (or >15%). Although bariatric surgery is recommended for obese patients with diabetes, there is little realistic prospect of it being offered to most such patients due to limited resources. In addition, many patients will not agree to surgery. However, there is clear evidence that a combined medical programme of diet, exercise and anti-obesity drugs can generate and maintain >15 kg weight loss for many patients. The aim of the study is to find out whether it is possible to reverse diabetes and sustain this over 2 years, similar to the benefits that are achieved through sustained weight loss after bariatric surgery. Optimised weight management via a proven structured programme, Counterweight Plus, will be used in GP surgeries. The study will also find out about the mechanisms underlying reversal of diabetes and quantify quality of life and attitudes during the study.

Who can participate ?
Patients in participating GP practices who have been diagnosed with type 2 diabetes within the previous 6 years, and who fulfil all inclusion criteria, will be invited to participate in the study.

What does the study involve?
GP practices will be recruited and randomly allocated to either to deliver usual care or to deliver Counterweight Plus, which includes a total diet replacement phase (TDR) followed by structured food reintroduction and long-term weight loss maintenance. Patients recruited in each participating GP practice will receive the care to which their practice has been allocated. All participants will be followed up at 1 and 2 years.

What are the possible benefits and risks of participating?
For patients who are successful in maintaining >15 kg loss, it is expected that many will revert to a non-diabetic state, and remain so for at least 2 years. There will be multiple clinical and personal benefits from any degree of weight loss, which are expected as long as any weight loss is maintained, for most patients and beyond the end of the study. There are no major risks from taking part in this study. The only significant risk from more intensive weight loss in the weight management programme arm is that gall-stones may become symptomatic. This is still relatively uncommon. This risk will be minimised by dietary provision which includes some fat consumption.

Where is the study run from?
The study is run from GP practices across Scotland and Tyneside, UK

When is the study starting and how long is it expected to run for?
The study will run for 5 years and recruitment will commence early in 2014

Who is funding the Study?
The study is funded by Diabetes UK

Who is the main contact?
Professor Mike Lean
Mike.Lean@glasgow.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mike Lean

ORCID ID

Contact details

Professor of Human Nutrition
University of Glasgow
4th Floor Walton Building
Glasgow Royal Infirmary
84 Castle St
Glasgow
G4 0SF
United Kingdom
-
Mike.Lean@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GN13DI127

Study information

Scientific title

Reversal of type 2 diabetes mellitus (T2DM) using non-surgical weight management with Low-Energy-Liquid-Diet and long-term maintenance, within routine NHS care

Acronym

DiRECT

Study hypothesis

Losing weight using a structured weight management programme which includes an initial period of total diet replacement, followed by carefully managed food reintroduction and then weight loss maintenance, is a viable treatment for putting T2DM into remission, and can be transferred to a larger scale as part of routine GP care, where large numbers of overweight people with T2DM are managed in the UK.

Ethics approval

West of Scotland Research Ethics Committee 3, 24/01/2014, REC reference: 13/WS/0314

Study design

Cluster randomised controlled design with GP practices as the unit of randomisation

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes

Intervention

Practices randomised to the intervention will deliver Counterweight Plus, which includes a Total Diet Replacement phase followed by structured food reintroduction and long-term weight loss maintenance. Training for the practice nurses/dietitians in TDR delivery, maintenance diet programme and behaviour therapy will be provided by the Counterweight (CW) Specialists, using the training package developed for the Counterweight feasibility study in primary care.

Week 0-12: a commercial micronutrient-replete 825-853 kcal/d TDR (soups and shakes) will be provided to replace normal foods, with ample fluids, for 12 weeks. Participants will be seen for review weekly then every 2 weeks during this phase.
Week 12-18: stepped transition to food-based Weight Maintenance, replacing TDR with meals which contain 30% of energy from fat. During this phase participants will attend for review appointments every 2 weeks.
Weeks 18-104: participants will then be provided with an individually tailored calorie prescription to support weight stabilisation and prevent weight regain with monthly review appointments.

All subjects in the intervention arm who are physically capable will be advised about increasing daily physical activity. As an aid, patients will be recommended to obtain an inexpensive step-counter and to aim to reach and maintain their individual sustainable maximum.

Some patients find weight maintenance difficult, some relapse temporarily and gain weight rapidly. Others may tend to let things slip more gradually. If weight regains occurs in TDR randomised participants, or if diabetes is found to have returned (HbA1c risen above 6.5%) at any time during the 18-month weight loss maintenance stage, ‘rescue plans’ for weight gain prevention will be offered.

Tyneside patients will be invited to participate in studies to define the physiological mechanisms underlying the long-term reversal of T2DM. These participants will have magnetic resonance measurements of pancreas and liver fat, assessment of beta-cell function and very low density lipoprotein (VLDL) secretion rate, and indirect calorimeter measurement of whole body substrate oxidation.

A random sample of control and intervention patients will be invited to participate in semi-structured interviews focusing on experiences, barriers, facilitators and successful strategies for self-control.

Practices randomised to control will continue to deliver usual optimal diabetes and obesity management as per clinical guidelines.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reduction in weight of 15 kg (assumed equal on average to 15%) or more

Co-primary outcome:
Reversal of diabetes (HbA1c <6.5%)

Both outcomes measured at 1 year

Secondary outcome measures

Changes in:
1. Quality of life measured by EQ-5D questionnaire
2. Physical activity level measured using Sensewear Monitor
3. Serum lipids, all at one year

Overall trial start date

01/01/2014

Overall trial end date

30/09/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Men and women aged 20-65 years, all ethnicities
2. T2DM of duration 0-6 years
3. Body Mass Index (BMI) >27 kg/m2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

280

Participant exclusion criteria

1. Current insulin use
2. HbA1c ≥12%
3. Substance abuse
4. Known cancer
5. Myocardial infarction within previous 6 months
6. Learning difficulties
7. Current treatment with anti-obesity drugs
8. Diagnosed eating disorder or purging
9. Pregnant/considering pregnancy
10. Patients who have required hospitalisation for depression or are on antipsychotic drugs

Recruitment start date

01/01/2014

Recruitment end date

05/08/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
Glasgow
G4 0SF
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde (UK)

Sponsor details

Research and Development Management Office
Tennent Institute
38 Church Street
Western Infirmary
Glasgow
G11 6NT
United Kingdom
-
Maureen.Travers@ggc.scot.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.nhsggc.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

Funder name

Cambridge Weight Plan (UK) - product and training support

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26879684

Publication citations

Additional files

Editorial Notes

17/02/2016: Publication reference added.