Condition category
Nutritional, Metabolic, Endocrine
Date applied
09/03/2011
Date assigned
30/03/2011
Last edited
06/01/2014
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 J.W.A. Smit

ORCID ID

Contact details

Leids Universitair Medisch Centrum
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P05.195

Study information

Scientific title

Myocardial metabolic flexibility and myocardial function in patients with complicated type 2 diabetes: a prospective intervention study

Acronym

Study hypothesis

To assess the effect of a short term very low calorie diet on myocardial triglyceride content and myocardial function in patients with complicated type 2 diabetes mellitus

Ethics approval

Medical Ethics Committee of the Leiden University Medical Centre, approved on 4th August 2008, reference: P05.195/SH

Study design

Prospective intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Type 2 diabetes mellitus

Intervention

Two magnetic resonance imaging (MRI)-scans will be performed in all patients. One baseline MRI-scan will be performed while patients have used their regular diet. A second MRI-scan after a 3-day very low calorie diet (450 kcal/day) (VLCD). During the VLCD the glucose lowering medication is adjusted to prevent hypoglycemia.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Myocardial triglcyeride content measured using proton MR spectroscopy
2. Cardiac function-measured by MRI

Measured at baseline and at day 4

Secondary outcome measures

1. Plasma free fatty acids-blood tests
2. Plasma glucose-blood tests
3. Waist fat

Measured at baseline and at day 4

Overall trial start date

10/02/2009

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with complicated type 2 diabetes mellitus, both men and women, age >18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

17

Participant exclusion criteria

1. Myocardial infarction
2. Congenital cardiac disease
3. Kidney failure
4. Pregnancy or lactation
5. Contra-indications for magnetic resonance imaging (MRI)

Recruitment start date

10/02/2009

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leids Universitair Medisch Centrum
Leiden
2333 ZA
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (Netherlands)

Sponsor details

Leiden University Medical Center
c/o Prof. J.W.A. Smit
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Center for Translational Molecular Medicine (Netherlands) [project PREDICCt (grant 01C-104)]

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Netherlands Heart Foundation (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Diabetes Research Foundation (Netherlands)

Alternative name(s)

Dutch Diabetes Research Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

Funder name

Dutch Kidney Foundation (Netherlands)

Alternative name(s)

Dutch Kidney Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Netherlands

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/24356600

Publication citations

  1. Results

    Jonker JT, Djaberi R, van Schinkel LD, Hammer S, Bus MT, Kerpershoek G, Kharagjitsingh AV, Romijn JA, Bax JJ, Jukema JW, de Roos A, Smit JW, Lamb HJ, Very-low-calorie diet increases myocardial triglyceride content and decreases diastolic left ventricular function in type 2 diabetes with cardiac complications., Diabetes Care, 2014, 37, 1, e1-2, doi: 10.2337/dc13-1423.

Additional files

Editorial Notes