Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/02/2011
Date assigned
05/04/2011
Last edited
16/07/2015
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

Mrs Ingrid Jazet

ORCID ID

Contact details

Albinusdreef 2
Leiden
2333 ZA
Netherlands

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

Sponsor information

Organisation

Leiden University Medical Center (Netherlands)

Sponsor details

Albinusdreef 2
Leiden
2333 ZA
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes