Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P05-033
Study information
Scientific title
Short and long term effect of a Very Low Calorie Diet (VLCD) with or without exercise in obese insulin-dependent type 2 diabetes mellitus patients: A randomised controlled trial
Acronym
Study hypothesis
1. The addition of exercise to a 16-week VLCD will normalise insulin sensitivity
2. The addition of exercise to a 16-week VLCD will further improve insulin signalling in the skeletal muscle cell
3. The addition of exercise to a 16-week VLCD improve quality of life insulin sensitivity long-term
4. The addition of exercise to a 16-week VLCD improve low-grade inflammation long-term
5. Prolonged caloric restriction will improve ectopic fat depositions in the heart, liver and pericardium
Ethics approval
Medical ethical committee of the Leiden University Medical Hospital, 08/06/2005
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Diabetes mellitus type 2
Intervention
One patients group followed a 16-week very low calorie diet.
The other patient group followed a 16-week very low calorie diet combined with an exercise program, which consisted of a one hour in-hospital training weekly, primarily aerobic exercise, under supervision of a physiotherapist. Also four training sessions at home on a cyclo-ergometer for 30 minutes at 70% of maximum aerobic capacity.
Measurements were performed at baseline, directly after the 16-week intervention and 18 months after start of the intervention.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Insulin sensitivity (as measured by hyperinsulinaemic euglycemic clamp)
2. Insulin signalling (measured in muscle biopsies)
3. Mitochondrial copy number (measured in muscle biopsies)
4. Low grade inflammation (measured in fasting blood samples)
5. Quality of Life (as measured by four different QoL questionnaires)
6. Ectopic fat depositions (as measured by magnetic resonance proton spectroscopy)
Secondary outcome measures
Long-term effects
Overall trial start date
01/05/2005
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Type 2 diabetes mellitus patients
2. Body mass index (BMI) > 30 kg/m2 (but weight has to be greater than 90 kg to sustain a 16 week VLCD)
3. Age > 30 years
4. Use of at least 30 units of insulin/day with or without oral blood glucose lowering agents
5. Fasting c-peptide level > 0.8 ng/l and a two times rise on 1 mg glucagon (intravenous) IV
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
28
Participant exclusion criteria
1. No residual insulin secretory capacity as defined by no response to a glucagon stimulation test
2. Weight above 130 kg and fasting plasma glucose >15 mmol/l
3. Any significant chronic disease
4. Renal, hepatic or another endocrine disease
5. Use of medication known to influence lipolysis and/or glucose metabolism
6. Recent weight changes or attempts to lose weight ( > 3 kg weight gain or loss, within the last 3 months)
7. Difficulties to insert an intravenous catheter
8. Smoking
9. Severe claustrophobia (ventilated hood)
10. Recent blood donation (within the last 3 months)
11. Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
12. Pregnancy
13. Disease interfering with the use of a thiazolidinediones (TZD) (heart failure, oedema, liver function abnormalities) or participating in regular exercise
Recruitment start date
01/05/2005
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Center (Netherlands)
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
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25415563