Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/09/2008
Date assigned
15/09/2008
Last edited
29/06/2016
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

Prof Iain Broom

ORCID ID

Contact details

The Robert Gordon University
Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
United Kingdom
-
j.broom@rgu.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

Ethics approval received from the North of Scotland Research Ethics Committees on the 15th April 2008 (ref: 08/S0801/54).

Study design

Single centred randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/04/2008

Overall trial end date

15/04/2010

Reason abandoned

Eligibility

Participant 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%)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

15/04/2008

Recruitment end date

15/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Robert Gordon University
Aberdeen
AB25 1HG
United Kingdom

Sponsor information

Organisation

The Robert Gordon University (UK)

Sponsor details

Centre for Obesity Research and Epidemiology
St. Andrew Street
Aberdeen
AB25 1HG
United Kingdom
-
j.broom@rgu.ac.uk

Sponsor type

University/education

Website

http://www.rgu.ac.uk/

Funders

Funder type

Industry

Funder name

Go Lower Limited (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

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