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

Recruiting

• Conditions: bloodsugar level; Gestational diabetes mellitus; insulin sensitivity; 10018424; 10026908

• Registration Number: NL-OMON33591
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Measurements will be conducted before randomisation (around 15 weeks of<br /><br>pregnancy), at 24 and 32 weeks of pregnancy and 12 weeks postpartum.<br /><br>Primary maternal outcome measures are fasting plasma glucose and relative<br /><br>increase in insulin resistance. Primary neonatal outcome is birth weight. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are: maternal serum triglycerides, maternal<br /><br>bodyweight gain during pregnancy, maternal physical activity level, fetal<br /><br>growth.</p><br>