The effects of an exercise program on insulin sensitivity and plasma glucose levels in women at high risk for gestational diabetes.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20927

Enrollment

160

Registered

2007-11-22

Start date

2007-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Gestational diabetes

Interventions

An exercise program consisting of aerobic and strength exercises will be provided twice a week during the remaining duration of the pregnancy after randomisation.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Between 14 and 20 weeks of pregnancy; 2. at risk for gestational diabetes mellitus; 3. over 25 years of age; 4. sufficiently fluent in Dutch; 5. being able to be moderately physically active; 6. giving written informed consent. Women will be considered to be at risk for GDM when they are overweight (BMI of 27 or more) AND have at least one of the three following characteristics: 1. history of macrosomia; 2. history of abnormal glucose tolerance; 3. first grade relative with diabetes mellitus type 2.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with (gestational) diabetes mellitus before randomisation; 2. hypertension; 3. systolic pressure >160mmHg and/or diastolic pressure >100mmHg; 4. alcohol abuse (i.e. 2 glasses alcohol or more per day); 5. use of drugs (except for incidental analgesic drugs); 6. serious pulmonary impairment; COPD, exercise-induced asthma; 7. serious cardiac impairment; angina pectoris, cardiac decompensation, history with cardiovascular disease; 8. serious hepatic impairment; 3 times the upper limit of normal; 9. serious renal impairment; serum creatinine > 150 ìmol/l; 10. malignant disease; 11. serious mental or physical impairment i.e. preventing to understand or implement the study protocol/aim.

Design outcomes

Primary

Measure	Time frame
Primary maternal outcome measures are fasting plasma glucose and relative increase in insulin resistance. Primary neonatal outcome is birth weight.	—

Secondary

Measure	Time frame
Secondary outcome measures are: maternal serum triglycerides, maternal weight gain during pregnancy, maternal physical activity level, fetal growth.	—

Contacts

Public ContactNicolette Oostdam

Van der Boechorststraat 7

n.oostdam@vumc.nl020 4441737

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)