To compare insulin sensitivity in full term neonates and preterm neonates at term, and to compare insulin sensitivity in small and appropriate for gestational age infants.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is insulin sensitivity measured by homeostasis model (IR-HOMA).
This requires a single blood sample for glucose and insulin concentrations.
Secondary outcome
Not applicable.
Background summary
Diabetes type 2 and other metabolic disorders have become an increasing problem
in today*s health care. It has been shown that insulin sensitivity already is
reduced at school-age in small for gestational age infants born full-term, and
also in premature neonates both appropriate (AGA) and small for gestational age
(SGA). This is ascribed to metabolic programming during fetal or early neonatal
life. No data are available on insulin sensitivity comparing term and preterm
infants, and AGA and SGA infants.
Study objective
To compare insulin sensitivity in full term neonates and preterm neonates at
term, and to compare insulin sensitivity in small and appropriate for
gestational age infants.
Study design
Observational study.
Study burden and risks
1. 1 ml of blood is needed for measurement of the plasma glucose and insulin
concentrations. In order to minimize the burden, the blood sample will be taken
simultaneously with a blood sample for clinical reasons (e.g. haemoglobin
concentration before discharge).
2. There is no direct benefit for the study population.
3. Group relatedness: Insulin resistance can progress into diabetes type 2.
Knowledge about the underlying pathophysiological mechanisms will lead to the
development of preventive and therapeutic strategies. There is a growing body
of evidence indicating that growth and nutrition during fetal and early
neonatal life plays an important role in the process of metabolic programming.
Reduced insulin sensitivity has been shown in children at school age. However,
data comparing insulin sensitivity in preterm vs. term infants and AGA vs. SGA
infants are lacking. In order to gain insight in the development of insulin
resistance, studies will have to be performed in newborn infants, thereby
involving minors.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16516.018.07 |