Contact information
Type
Scientific
Primary contact
Dr A Scott
ORCID ID
Contact details
Southern Derbyshire Acute Hospitals NHS Trust
Jenny O'Neil Centre/Diabetes
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 (0)1332 347141 ext 2284
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077107001
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Drug names
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 trial start date
20/02/2002
Overall trial end date
01/09/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
20/02/2002
Recruitment end date
01/09/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Southern Derbyshire Acute Hospitals NHS Trust (UK)
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
Basic results (scientific)
Publication list