Low-carbohydrate high-protein diet in obese diabetic subjects

ISRCTN	ISRCTN20400186
DOI	https://doi.org/10.1186/ISRCTN20400186
Secondary identifying numbers	N/A

Submission date: 05/09/2008
Registration date: 15/09/2008
Last edited: 29/06/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Iain Broom
Scientific

The Robert Gordon University
Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
United Kingdom

Email	j.broom@rgu.ac.uk

Study information

Study design	Single centred randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Alterations in the macronutrient content of the diet and effects on body composition, cardiovascular disease risk and the control of energy metabolism in obese patients with type II diabetes mellitus
Study objectives	To assess the weight loss achieved after 12 months on one of two hypoenergetic low-carbohydrate, high-protein diets (the protein sparing modified fast compared to commercial diet provided by the Go Lower company).
Ethics approval(s)	Ethics approval received from the North of Scotland Research Ethics Committees on the 15th April 2008 (ref: 08/S0801/54).
Health condition(s) or problem(s) studied	Obese, type 2 diabetics
Intervention	Patients will be assigned to either the protein sparing modified fast (PSMF) or the Go Lower diet. In both instances, patients will be given oral and written information about the diet. Patients on Go Lower will be given weekly food packs while the patients on PSMF will prepare their own food. Patients will be seen at 2 and 4 weeks post-randomisation and then monthly for a total of 1 year.
Intervention type	Other
Primary outcome measure	Weight change, measured in kilograms at baseline, 3, 6, 9 and 23 months.
Secondary outcome measures	1. Changes in cardiovascular risk, measured by looking at total cholesterol, triacylglycerols, high density lipoprotein (HDL), low-density lipoprotein (LDL), C-reactive protein (mg/L), fasting glucose (all in mmol/L), fasting insulin (uU/ml), HbA1c (%), waist circumference (cm), blood pressure (mmHg) 2. Glycaemic control will be measured using fasting glucose, fasting insulin and HbA1c 3. Metabolic rate is being measured using the ventilated hood (Quark RMR machine) from COSMED 4. Liver function will be assessed by measuring albumin (g/L), total bilirubin (umol/L), alkaline phosphatase, alanine aminotransferase and gamma-glutamyl transferase (U/L). For kidney function we will measure urea (mmol/L) and creatinine (umol/L) and calculate the estimated glomerular filtration. 5. Quality of life, measured using the following questionnaires: Weight: Decisional Balance, Orwell 97, Diabetes treatment satisfaction questionnaire, Audit of Diabetes-Dependent quality of life, Lee fatigue scale, General Practice Physical activity questionnaire, Major (ICD-10) depression inventory and the Epworth Sleepiness Scale 6. Changes in adipokines These will all be measured at baseline, 3, 6, 9 and 23 months.
Overall study start date	15/04/2008
Completion date	15/04/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	120
Key inclusion criteria	1. Men and women between 18 and 75 years of age 2. Body Mass Index (BMI) greater than or equal to 30 kg/m^2 3. Poorly controlled type II diabetes mellitus (HbA1c greater than or equal to 7.5%)
Key exclusion criteria	1. A history or current renal, hepatic disease or cancer 2. Have had a major coronary event in the last 6 months 3. Diet related diseases 4. On antidepressant or obesity-related pharmacotherapy 5. Current pregnancy or lactating
Date of first enrolment	15/04/2008
Date of final enrolment	15/04/2010

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

The Robert Gordon University

Aberdeen
AB25 1HG
United Kingdom

Sponsor information

The Robert Gordon University (UK)
University/education

Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
Scotland
United Kingdom

Email	j.broom@rgu.ac.uk
Website	http://www.rgu.ac.uk/
"ROR"	https://ror.org/04f0qj703

Funders

Funder type

Industry

Go Lower Limited (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

29/06/2016: No publications found, verifying study status with principal investigator