Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/12/2013
Date assigned
21/01/2014
Last edited
01/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is evidence that low carbohydrate/high protein diets lead to improvements in weight, diabetic control and certain biochemical markers in patients with type 2 diabetes. This study will investigate the impact of the Dukan diet on diabetic control and a wider variety of biochemical markers than have previously been studied; this will give an indication of the safety of the diet. The aim to find out if a low carbohydrate/high protein diet leads to improvements in risk factors for heart disease and other complications in obese patients with type 2 diabetes.

Who can participate?
The study aims to recruit 32 obese males and females with type 2 diabetes mellitus, aged18-75 from the City Walls Medical Centre, Chester, UK.

What does the study involve?
Participants will be randomly to one of two groups: one group will follow a low carbohydrate/high protein diet for eight weeks and the other 16 participants will follow a low-fat diet with 500-600kcal/day energy deficit. Participants will attend three clinic appointments during the eight week study. Dietary education will be provided at the first appointment; participants will be given instructions by a dietitian on how to follow either the low carbohydrate/high protein diet or a low-fat 500-600kcal deficit diet and written information will be provided. Adherence to the diet will be monitored at follow-up through a three day diet diary and dietary interviews. At each appointment, weight, height, waist circumference, percentage body fat and blood pressure will be measured and fasted blood samples will be taken.

What are the possible benefits and risks of participating?
The potential benefits for research participants in both study groups are an improvement in diabetic control, a reduction in weight and reduced risk of long-term complications including cardiovascular disease, renal disease and liver complications. While undertaking the study participants will benefit from more regular dietetic input and increased access to the dietitian than they would receive in standard care. There is potential burden on participants in the study due to increased contact with the dietitian, the changes in lifestyle associated with following a new diet, and the burden of completing diet diaries. There will be regular dietetic support to help participants follow the diets; the diet diary will also help with this and is an important tool for monitoring participant compliance. The burden of increased contact will be limited as the visits will be held at the participants' normal GP surgery. The other potential risk to the participant is that associated with obtaining blood samples; this will be minimized as fully trained nurses/phlebotomists will be responsible for collecting these samples.

Where is the study run from?
The study is run by the University of Chester; appointments will take place at the City Walls
Medical Centre, Chester, UK

When is the study starting and how long is it expected to run for?
It is anticipated that recruitment will start at the beginning of 2014. Participants will be enrolled on the study for a period of eight weeks, and overall the study is expected to be completed at the start of 2015.

Who is funding the study?
Funding has been provided by the Dukan Organisation (http://www.dukandiet.co.uk/).

Who is the main contact?
Dr Sohail Mushtaq, s.mushtaq@chester.ac.uk
Jennifer Saxon, jenniferssaxon@yahoo.co.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sohail Mushtaq

ORCID ID

Contact details

Department of Clinical Sciences and Nutrition
University of Chester
Parkgate Road
Chester
CH1 4BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pilot investigation into the effect of a low carbohydrate/high protein diet on cardiometabolic risk factors in obese patients with type 2 diabetes. An eight-week randomised controlled trial

Acronym

Study hypothesis

Does an eight-week low carbohydrate/high protein dietary intervention lead to improvements in cardiometabolic risk factors in obese patients with type 2 diabetes?

Ethics approval

NRES Committee North West - Liverpool East, 04/02/2014, ref: 13/NW/0864, amendments approved 29/08/2014

Study design

Single-centre randomised controlled trial

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 the contact details to request a patient information sheet

Condition

Type 2 diabetes mellitus

Intervention

The intervention group will follow a low carbohydrate/high protein 'Dukan' diet.
The control group will follow a low-fat 500-600 kcal energy-deficit diet.
The total duration of the intervention is 8 weeks for both study arms; there is no follow-up planned.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Blood samples will be taken by phlebotomists/practice nurses working at the City Walls Medical Practice. They will be analysed at the Countess of Chester laboratory which is accredited by CPA (UK) Ltd. The following will be measured:
1. Fasting plasma glucose/fasting plasma insulin
2. Glycosylated haemoglobin
3. Lipid profile (total serum cholesterol, HDL serum cholesterol, fasting serum triglycerides - from these LDL cholesterol and cholesterol/HDL ratio will also be calculated)
4. Kidney function (serum creatinine and urea, eGFR will then be calculated)
5. Liver function tests (gamma glutamyl transpeptidase, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, albumin, total protein, bilirubin)
6. Serum potassium, serum sodium, C-reactive protein
7. Serum ketones
8. Measures of oxidative stress (e-selectin, ICAM, vWF, MDA, 15-F2t isoprostane)

All outcomes will be measured at baseline and at 8 weeks.

Secondary outcome measures

Current secondary outcome measures as of 28/04/2014:
1. Anthropometric measures of height, weight and waist circumference will be measured using methods outlined in the Manual of Dietetic Practice
2. Blood pressure

All outcomes will be measured at baseline and at 8 weeks; in addition the secondary outcomes will be measured at 4-week interim.

Previous secondary outcome measures:
Anthropometric measures of height, weight and waist circumference will be measured using methods outlined in the Manual of Dietetic Practice.

All outcomes will be measured at baseline and at 8 weeks; in addition the secondary outcomes will be measured at 4-week interim.

Overall trial start date

03/02/2014

Overall trial end date

07/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 18/09/2014:
1. Male or female, aged 18-75
2. BMI 28-40 kg/m*2
3. HbA1c <86 mmol and a diagnosis of diabetes confirming to WHO guidelines
4. Stable medication at least three months prior to the study
5. Diabetes managed with Metformin or lifestyle only
6. English speaking with internet access

Previous inclusion criteria:
1. Male or female, aged 18-75
2. BMI 28-40 kg/m*2
3. HbA1c <64 mmol and a diagnosis of diabetes conforming to WHO guidelines
4. Stable medication at least three months prior to the study
5. Diabetes managed with Metformin or lifestyle only
6. English speaking with internet access

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

32

Participant exclusion criteria

Current exclusion criteria as of 18/09/2014:
1. History of eating disorder
2. Currently following a restrictive diet
3. Currently taking part in other research
4. Impaired kidney function
5. Impaired liver function
6. Patients taking medications to reduce blood clots
7. Pregnant women
8. Non-English speaking
9. No internet access

Previous exclusion criteria:
1. History of eating disorder
2. Currently following a restrictive diet
3. Currently taking part in other research
4. Impaired kidney function
5. Impaired liver function
6. Patients taking medications to reduce blood clots or promote production of urine
7. Pregnant women
8. Non-English speaking
9. No internet access

Recruitment start date

23/04/2014

Recruitment end date

02/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Chester
Chester
CH1 4BJ
United Kingdom

Sponsor information

Organisation

University of Chester (UK)

Sponsor details

c/o Mark Helsdon
Research
Postgraduate and Knowledge Transfer Services
Parkgate Road
Chester
CH1 4BJ
United Kingdom

Sponsor type

University/education

Website

http://www.chester.ac.uk/

Funders

Funder type

University/education

Funder name

Regime Dukan (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Chester (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The results will primarily be published in a student thesis, forming part of a Masters by Research. Additionally, the intention is to report and disseminate the results of the study through peer-reviewed scientific journals and conference presentations.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/04/2015: the overall trial end date was changed from 02/02/2015 to 07/10/2015.