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Insulin sensitivity in appropriate for gestational age and small for gestational age term and preterm infants

Conditions
decreased sensitivity to blood sugar regulating hormone
insulin sensitivity
10018424
10028920
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
Inclusion Criteria

- 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)

Exclusion Criteria

- 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
NameTimeMethod
<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
NameTimeMethod
<p>Not applicable.</p><br>
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