The overall aim of the study: To assess whether an exercise program can improve insulin sensitivity and fasting plasma glucose levels of women at high risk for gestational diabetes, assuming that this will normalise their risk of gestational…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Measurements will be conducted before randomisation (around 15 weeks of
pregnancy), at 24 and 32 weeks of pregnancy and 12 weeks postpartum.
Primary maternal outcome measures are fasting plasma glucose and relative
increase in insulin resistance. Primary neonatal outcome is birth weight.
Secondary outcome
Secondary outcome measures are: maternal serum triglycerides, maternal
bodyweight gain during pregnancy, maternal physical activity level, fetal
growth.
Background summary
Pregnancy is a period in the live of women that may result in decreased daily
physical activity and/or exercise. This change often occurs despite the fact
that there is no medical reason for women to reduce their daily physical
activity levels and/or exercise. However, maintaining adequate levels of daily
physical activity during pregnancy may be important for mother and child.
Studies of daily physical activity or exercise and the occurrence of maternal
pregnancy related disorders suggest that moderate daily physical activity and
exercise during pregnancy may be associated with reductions in the risk of
gestational diabetes mellitus (GDM). However, at the moment, physical activity
is not routinely advised or prescribed for women at risk for gestational
diabetes in the Netherlands.
Study objective
The overall aim of the study: To assess whether an exercise program can improve
insulin sensitivity and fasting plasma glucose levels of women at high risk for
gestational diabetes, assuming that this will normalise their risk of
gestational diabetes. Secondary objectives: Measure the effect of an exercise
program on birth weight and the compliance with the exercise program and what
factors contribute to the success or failure of the program.
Study design
This study is a randomised controlled trial. 160 women at risk for gestational
diabetes will be randomly allocated to two groups; an intervention (n = 80) and
a control group (n = 80).
Intervention
The intervention group will receive a twice a week an exercise program in
addition to usual care, and the control group will receive usual care.
Study burden and risks
The intervention will be an exercise program twice a week during the remaining
duration of the pregnancy. Trainers have expertise with providing training for
pregnant women. Exercises will be adjusted to the fitness and endurance level
of the women at the start of the intervention and later on to their stage of
pregnancy. When they follow the guide of the ACOG the exercise program will be
safe and healthy.
The training program will take some time from the women, but it will lower the
risk of gestational diabetes. The measurements do not pose a risk, but it will
also take time of the women. However pregnant women are often very motivated
participants, especially when it may be important for their pregnancy outcome.
van der Boechorststraat 7
1081 BT Amsterdam
NL
van der Boechorststraat 7
1081 BT Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria are:
-between 14 and 20 weeks of pregnancy,
-at risk for gestational diabetes mellitus (GDM),
-over 18 years of age,
-sufficiently fluent in Dutch,
-able to be moderately physically active;Women will be considered to be at risk for GDM when they have:
- BMI * 30
or
- BMI * 25 AND a, b or c
a) history of macrosomia;
b) history of abnormal glucose tolerance;
c) first grade relative with diabetes mellitus type 2.
Exclusion criteria
Exclusion criteria are:
- diagnosed with (gestational) diabetes mellitus before randomisation
- hypertension (systolic pressure > 160mmHg and/or diastolic pressure >100mmHg)
- alcohol abuse (i.e. 2 glasses alcohol or more per day),
- use of drugs (except for incidental analgesic agents)
- serious pulmonary impairment; COPD, exercise-induced asthma
- serious cardiac impairment; angina pectoris, cardiac decompensation, history with cardiovascular disease,
- serious hepatic impairment; 3 times the upper limit of normal,
- serious renal impairment; serum creatinine > 150 *mol/l,
- malignant disease
- serious mental or physical impairment i.e. preventing to understand or implement the study protocol / aim.
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 | NL17962.029.07 |