The main objectives of this study are:To obtain insight into differences in VF markers between lean and abdominally overweight / obese men.To study cross-sectional relationships between VF markers.To determine the effects of weight-loss in…
ID
Source
Brief title
Condition
- Lipid metabolism disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Parameters related to in vivo VF markers will be studied.
The primary endpoint is the difference in flow mediated dilation (FMD) of the
brachial artery
- between lean and abdominally overweight / obese male subjects.
- in abdominally overweight / obese men after weight-loss due to restriction of
energy intake
Secondary outcome
Secondary endpoints are differences in * and relations between * other VF
measurements and of plasma biomarkers related to low-grade inflammation and
vascular activity
- between lean and abdominally overweight / obese male subjects
- in abdominally overweight / obese men after weight-loss dure to restriction
of energy intake
- during the fasting and postprandial / hyperinsulinemic state
Background summary
An increased body mass impairs vascular function (VF), an important
characteristic of subjects suffering from type 2 diabetes and a risk marker for
cardiovascular diseases. However, a wide variety of in vivo VF markers exists
each measuring different aspects of VF. Each of these markers addresses a
different aspect of the vasculature. Studies comparing under standardized
conditions the differences and relationships of the many different VF
measurements in lean and abdominally overweight / obese subjects are missing.
Also, there is a great need to know which of these markers are sensitive to
dietary challenges.
Study objective
The main objectives of this study are:
To obtain insight into differences in VF markers between lean and abdominally
overweight / obese men.
To study cross-sectional relationships between VF markers.
To determine the effects of weight-loss in abdominally overweight / obese men
on VF markers during the fasting and postprandial state.
To determine the effects of weight-loss in abdominally overweight / obese men
on VF markers during the fasting and hyperinsulinemic state.
To study in abdominally overweight / obese men relationships between changes in
VF markers after weight-loss.
Study design
At baseline, lean and abdominally overweight / obese male subjects have to
attend on two days the research facilities to perform the VF measurements.
Measurements will be performed during the postprandial phase and during a
hyperinsulinemic clamp. The abdominally overweight / obese men will then be
randomly assigned to a weight-loss program or to a no-weight loss (*control*)
treatment. After this period, measurements will be repeated. After these
measurements, subjects from the control group will be given the possibility to
loose weight using the same weight-loss program, but without any measurements.
Intervention
Lean subjects will only be studied cross-sectionally, and obese / overweight
subjects before and after random assignment to a weight-loss intervention.
Subjects assigned to the energy-intake restricted weight-loss intervention will
consume a very-low energy diet between 4-5 weeks providing 2.1 MJ/day. Once the
waist circumference within this period is below 102 cm, subjects will consume a
mixed solid energy-restricted diet providing 4.2 MJ/day for the following 1 - 2
weeks. Then they will be fed for at least 2 weeks a diet matching their energy
requirements (weight-stable conditions). The total intervention period will
last 8 weeks. Subjects assigned to the control condition will maintain their
habitual diet.
Study burden and risks
Before the start of the study, all subjects will be screened to determine
eligibility during a visit of respectively 20 minutes. During this, body
weight, height, waist circumference and blood pressure will be measured. In
addition, a venous blood sample (5.5mL) will be drawn.
Following screening, all participants will visit our research facilities at
Maastricht University Medical Center two times: once for a postprandial test (7
hours) and once for a hyperinsulinemic euglycemic clamp (7 hours). During this
period, subjects will remain at the MUMC. In addition, abdominally overweight /
obese subjects will visit our research facilities every week during the
intervention period, and three times at the end of the intervention period:
once for a postprandial test (7 hours), once for a hyperinsulimenic euglycemic
clamp (7 hours), and once for fMRI measurements (1 hour). fMRI measurements
will be done in 30 overweight / obese subjects. Total time investment for the
lean and abdominally overweight / obese subjects will be approximately 885
(14.75 hours) and 1860 (control group) - 1890 (intervention group) minutes (31
- 31.5 hours). fMRI measurements will take 60 minutes (1 hour).
The amount of blood drawn will be 209 mL (5.5 mL during the screening visit,
113.5 mL at the postprandial test day, and 90 mL at the hyperinsulinemic test
day) per lean and 412.5 mL per abdominally overweight / obese male subject
during the whole study. Therefore, subjects are not allowed to have donated
blood 8 weeks prior to participation.
Lean participants will have no direct health benefit from participation,
whereas abdominally overweight / obese subjects will be facilitated to loose
weight (either as intervention or after completion of the control treatment).
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- Aged between 18 and 65 years
- Waist circumference below 94 cm or between 102-110 cm
- Caucasian
- Mean plasma glucose < 7.0 mmol/L
- Mean serum total cholesterol < 8.0 mmol/L
- Mean triaclglycerol < 4.5 mmol/L
- Plasma Hba1c < 6.5%
- No current smoker
- No diabetic patients or individuals receiving antidiabetic medication
- No familial hypercholesterolemia
- No abuse of drugs
- Less than 14 alcoholic consumptions per week
- Stable body weight (weight gain or loss <3 kg in the past three months)
- No use of medication known to affect bood pressure, serum lipid or glucose metabolism
- No indication for blood pressure lowering treatment
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- No active cardiovascular disease like congestive heart failure or cardiovascular event, such as an acute myocardial infarction or cerebro vascular accident
- No contra-indications for MRI imaging (e.g. pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia)
- Willingness to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study
- No difficult venipuncture as evidenced during the screening visit
- Willingness to stop the consumption of vitamins, minerals and (food) supplements from 3 weeks before the start of the study and during the study
Exclusion criteria
- Women
- Non-caucasian
- Mean plasma glucose * 7.0 mmol/L
- Mean serum total cholesterol * 8.0 mmol/L
- Mean triaclglycerol * 4.5 mmol/L
- Plasma HbA1c * 6.5%
- Current smoker, or smoking cessation < 12 months
- Diabetic patients or individuals receiving antidiabetic medication
- Familial hypercholesterolemia
- Abuse of drugs
- More than 14 alcoholic consumptions per week
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Use of use of medication known to affect blood pressure, serum lipid or glucose metabolism
- Indication for blood pressure lowering treatment
- No severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases, auto inflammatory diseases and rheumatoid arthritis
- Active cardiovascular disease like congestive heart failure or recent (< 6 months) event, such as an acute myocardial infarction or cerebro vascular accident
- Contra-indications for MRI imaging (e.g. pacemaker, surgical clips/materials in body, metal splinter in eye, claustrophobia)
- Use of an investigational product within the previous 1-month
- Not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study, during the study or for 4 weeks after completion of the study
- Not or difficult to venipuncture as evidenced during the screening visit
- Not willing to stop the consumption of vitamins, minerals o (food) supplements from 3 weeks before the start of the study and during the study
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 | NL41397.068.12 |