Insulin sensitivity in preterm AGA and SGA infants.
- Conditions
- Insulin sensitivy, insuline sensitiviteitPrematurity, prematuriteitSmall for gestational age, dysmaturiteit
- Registration Number
- NL-OMON28578
- Lead Sponsor
- Drs I.A. ZonnenbergAcademisch Medisch CentrumNeonatologie, H3-213Meibergdreef 91105 AZ Amsterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 16
1. Premature infants 28-32 weeks gestational age;
2. Presence of a (central) venous and arterial catheter for clinical reasons;
3. For preterm SGA infants: growth retardation caused by placental insufficiency, assessed by maternal history (pregnancy induced hypertension, preeclampsia), and confirmed by Doppler flow measurements of the umbilical arteries (Pulsatility index, PI, >+2 SD for gestational age, measured on two occasions)
1. For preterm SGA infants: growth retardation based on other causes (e.g. congenital infections, congenital malformations);
2. Major congenital malformations;
3. Severe perinatal asphyxia defined as 5 minute Apgar score <7;
4. Severe disturbances of glucose metabolism (glucose intake <4 or >8 mg.kg-1.min-1, or need for insulin therapy to maintain the glucose concentration between 2.6 and 8 mmol/l);
5. Severe respiratory distress. Mild ventilatory support is allowed:
a. nCPAP with maximum FiO2 of 0.40, maximum PEEP 6 cm H2O;
b. SIMV with maximum inspiratory peak pressure of 18 cm H2O and maximum FiO2 of 0.40;
c. HFOV with maximum continuous distending pressure of 12 cm H2O and maximum FiO2 of 0.30;
6. Need of vasopressor support for hypotension;
7. Treatment with systemic corticosteroids;
8. Clinical or laboratory evidence of sepsis: 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;
9. Low haemoglobin level at the study days with need for a blood transfusion;
10. Positive family history for type 2 diabetes in first degree relatives;
11. No informed consent from parents or legal guardians.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of appearance and disappearance of glucose during insulin infusion
- Secondary Outcome Measures
Name Time Method 1. Rate of gluconeogenesis and glycogenolysis; <br>2. Plasma FFA concentrations; <br>3. Plasma concentrations of insulin, cortisol and adiponectin. <br>