Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes