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
| ISRCTN | ISRCTN76920690 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76920690 |
| Secondary identifying numbers | P05-033 |
- Submission date
- 23/02/2011
- Registration date
- 05/04/2011
- Last edited
- 16/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Ingrid Jazet
Scientific
Scientific
Albinusdreef 2
Leiden
2333 ZA
Netherlands
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Medical ethical committee of the Leiden University Medical Hospital, 08/06/2005 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2005 |
| Completion date | 01/09/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 28 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/09/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
Leiden University Medical Center (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Albinusdreef 2
Leiden
2333 ZA
Netherlands
"ROR" |
https://ror.org/05xvt9f17 |
|---|
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Center (Netherlands)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/11/2014 | Yes | No |
