Comparison of intermittent use of a very low calorie diet (VLC) versus Orlistat for weight maintenance in the management of obese patients with type 2 diabetes

ISRCTN	ISRCTN74116743
DOI	https://doi.org/10.1186/ISRCTN74116743
Secondary identifying numbers	N0077107001

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 05/12/2014

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

Dr A Scott
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
Jenny O'Neil Centre/Diabetes
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Phone	+44 (0)1332 347141 ext 2284
Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Comparison of intermittent use of a very low calorie diet (VLC) versus Orlistat for weight maintenance in the management of obese patients with type 2 diabetes
Study objectives	We postulate that recurrent periods of VLCD (Pulsed VLCD) may be as effective for weight maintenance as Orlistat in managing obesity in Type 2 Diabetes Mellitus.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nutritional, Metabolic, Endocrine: Obesity
Intervention	After medical and dietetic assessment, patients will receive a VLC diet (approx 700 cal) for no more than 3 months until 10 kg or 12% weight loss is achieved. Patients will be randomised to either 'Pulsed VLCD' or Orlistat 120 mg. tds and followed up over 12 months. The schedule of visits will be Week 0, 2, 4, 8, 12, 16, 20, 36, 52, with telephone visits at weeks 24, 28,and 32. At each visit patients will have a dietary review, weight and blood pressure check. The ADDPoL, WBQ22 and DSTQs and DTSQC questionnaire will be used to assess quality of life, well-being and diabetic treatment satisfaction.
Intervention type	Mixed
Primary outcome measure	1. Weight loss, improvement of cardiovascular risk 2. Improvement of blood pressure (BP) 3. Improvement of psychological outcome
Secondary outcome measures	Not provided at time of registration
Overall study start date	20/02/2002
Completion date	01/09/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Patients with type 2 diabetes attending the Jenny O'Neill Diabetes Centre and patients attending Primary Care diabetes clinics 2. Who are overweight (Body Mass Index [BMI] >28) 3. Who are either on maximal or near maximal doses of oral hypoglycaemics or are insulin treated but have poor control (HbA1c >7.59) and are motivated to lose weight
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	20/02/2002
Date of final enrolment	01/09/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE1 2QY
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Southern Derbyshire Acute Hospitals NHS Trust (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