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

The effect of an exercise program on insulin sensitivity and plasma glucose levels in women at risk for gestational diabetes mellitus. - Fit For 2 Study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33591

Enrollment

160

Registered

2007-07-18

Start date

2007-09-26

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

bloodsugar level Gestational diabetes mellitus insulin sensitivity

Interventions

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.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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: 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 outcomes

Primary

Measure	Time frame
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

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)