-Determination of the effects of an exercise program on ectopic fat accumulation in heart, liver and skeletal muscle-To assess the relationship between metabolic and inflammatory parameters with changes in MRI outcome-To assess the differences in…
ID
Source
Brief title
Condition
- Heart failures
- Diabetic complications
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hepatic, myocardial and muscle triglyceride content and cardiac function
Secondary outcome
Antropometric measurements, biochemical values and basal metabolic rate.
Background summary
Background
Ectopic fat accumulation is common in type 2 diabetes and is associated with
insulin resistance, a worsening of glycemic control, lipid abnormalities and
increased risk for cardiovascular disease. It occurs in heart, liver and
skeletal muscle. Life style changes are a pillar of therapy. Although changes
in diet could have beneficial effects on ectopic fat accumulation, this is less
clear during exercise training. It is also unclear how ectopic fat deposits in
different organs relate to each other at baseline and during the exercise
program.
Study objective
-Determination of the effects of an exercise program on ectopic fat
accumulation in heart, liver and skeletal muscle
-To assess the relationship between metabolic and inflammatory parameters with
changes in MRI outcome
-To assess the differences in ectopic fat accumulation in female diabetic
patients and female healthy controls at baseline
Study design
Open, prospective intervention study with duration of 6 months
Intervention
Exercise program during 6 months
All patients will receive an individualised exercise program. Every month
patients will report the amount of exercise, details on diet and they will
carry the SenseWear during this week to measure caloric consumption. Each
patient will have a coach.
The healthy controles will only get a baseline MRI-scan, but no intervention
Study burden and risks
The individualised exercise program stimulates patients to exercise 5 times a
week for minimal 30 minutes per training. This program including a coach, does
not cost the patients extra money.
The burden of the study includes the two MRI-scans, during which patients have
to lie still. We expect no harmful effects of the MRI-scan, if
contra-indications are carefully checked.
Albinusdreef 2
2333 ZA LEIDEN
NL
Albinusdreef 2
2333 ZA LEIDEN
NL
Listed location countries
Age
Inclusion criteria
Group A: Diabetes mellitus type 2, Age>18 years, informed consent
Group B: Age and BMI matched female healthy controls, Age >18 years, informed consent
Exclusion criteria
Group A: (congenital) heart disease; liver disease (increased ALAT and GGT); renal disease (creatine above reference level); muscular diseases; BMI > 36 kg/m2; MRI contra-indications;Group B: same as group B + no diabetes mellitus + no pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL31412.058.10 |