Insulin sensitivity in appropriate for gestational age and small for gestational age term and preterm infants
- Conditions
- decreased sensitivity to blood sugar regulating hormoneinsulin sensitivity1001842410028920
- Registration Number
- NL-OMON31057
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
- Need for blood sampling on a clinical indication, e.g. for neonatal screening program or before discharge home.
- (Near) term age at the moment of blood sampling (corrected postconceptional age 36-42 weeks)
- Full oral or enteral nutrition (>120 ml/kg/day)
- Uncertain gestational age
- Supplementary intravenous nutrition (parenteral nutrition or glucose infusion)
- Disturbances in glucose metabolism (hypo- or hyperglycemia at a normal carbohydrate intake, or need for insulin therapy to maintain glucose concentration between 2.6 and 8 mmol/l)
- Need for medication interfering with glucose metabolism (vasopressors, corticosteroids)
- Positive family history of type 2 diabetes in first degree relatives
- Perinatal asphyxia (5 minute Apgar score <7)
- Current infection (clinical or laboratory evidence: lethargy or irritability, hypo- or hyperthermia, temperature instability, tachypnea, apnea, bradycardia, hypotension, gastric retention, abdominal distension, pallor, elevated CRP-level, leukocytosis or leukocytopenia and increased number of band neutrophils)
- No informed consent from parents or legal guardians
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary outcome is insulin sensitivity measured by homeostasis model (IR-HOMA).<br /><br>This requires a single blood sample for glucose and insulin concentrations. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>