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
Protocol serial number	P05-033
Sponsor	Leiden University Medical Center (Netherlands)
Funder	Leiden University Medical Center (Netherlands)

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

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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)
Key secondary outcome measure(s)	Long-term effects
Completion date	01/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes