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

ISRCTN	ISRCTN45943101
DOI	https://doi.org/10.1186/ISRCTN45943101
Secondary identifying numbers	NL874 (NTR888)

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 26/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof H P Sauerwein
Scientific

Academic Medical Centre (AMC)
Department of Endocrinology and Metabolism, F5-170
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 3061
Email	h.p.sauerwein@amc.uva.nl

Study information

Study design	Observational study
Primary study design	Observational
Secondary study design	Multi-centre
Study setting(s)	Not specified
Study type	Other
Scientific title	Insulin sensitivity in preterm appropriate-for-gestational-age and small-for-gestational-age infants
Study objectives	Insulin sensitivity is already reduced at birth in preterm Small-for-Gestational-Age (SGA) infants, compared to preterm Appropriate-for-Gestational-Age (AGA) infants.
Ethics approval(s)	Approval received from the Central Committee on Research inv. Human Subjects on the 30th January 2006 (ref: P05.1488C).
Health condition(s) or problem(s) studied	Small for gestational age, prematurity, insulin sensitivity
Intervention	Methods used: 1. Glucose concentration: this will be measured with the glucose oxidase method using a Beckman Glucose Analyzer 2 (Beckman, Fullerton, CA) 2. Insulin: this will be determined with a chemiluminescent immunometric assay (Immulite 2000, Diagnostic Products Corporation, Los Angeles, USA) 3. Free Fatty Acid (FFA) concentration: this will be determined with an enzymatic colorimetric method (NEFA-C test kit, Wako Chemicals GmbH, Neuss, Germany) 4. Cortisol: this will be determined with a chemiluminiscent immunoassay (Immulite 2000, Diagnostic Products Corporation, Los Angeles, USA) 5. Adiponectin: this will be determined by a radioimmunoassay (Linco, St. Charles, USA) 6. Stable isotope measurements: Newborns are infused with [U-13C] glucose and [2-13C] glycerol. Isotope dilution and label incorporation will be determined by gas chromatography mass spectrometry (GCMS) and mass isotopomer distribution analysis (MIDA) in glucose, isolated from plasma Calculations: 1. Rate of appearance (Ra) of glucose during steady state is calculated by the isotope dilution technique from the [U-13C] enrichment of glucose, using calculations for steady state kinetics, adapted for the use of stable isotopes: Ra = (Ei/Ep) × I, where Ei and Ep are the enrichments of infusate and plasma respectively, and I is the infusion rate of [U-13C] glucose 2. Rate of disappearance (Rd): rate of exogenous glucose infusion plus the rate of endogenous glucose production 3. Endogenous glucose production: Rate of appearance minus rate of exogenous glucose infusion 4. Absolute gluconeogenesis: fractional gluconeogenesis (measured by MIDA) times rate of appearance 5. Glycogenolysis: Endogenous glucose production minus absolute gluconeogenesis
Intervention type	Other
Primary outcome measure	Rate of appearance and disappearance of glucose during insulin infusion
Secondary outcome measures	1. Rate of gluconeogenesis and glycogenolysis 2. Plasma Free Fatty Acid (FFA) concentrations 3. Plasma concentrations of insulin, cortisol and adiponectin
Overall study start date	01/04/2007
Completion date	01/04/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Not Specified
Target number of participants	16
Key inclusion criteria	1. Premature infants 28 to 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] more than +2 Standard Deviation [SD] for gestational age, measured on two occasions)
Key exclusion criteria	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 five minute Apgar score less than seven 4. Severe disturbances of glucose metabolism (glucose intake less than 4 or more than 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. nasal Continuous Positive Airway Pressure (nCPAP) with maximum Fraction of Inspired Oxygen (FiO2) of 0.40, maximum Positive End Expiratory Pressure (PEEP) 6 cm Water (H2O) b. Synchronised Intermittent Mandatory Ventilation (SIMV) with maximum inspiratory peak pressure of 18 cm H2O and maximum FiO2 of 0.40 c. High Frequency Oscillatory Ventilation (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 C- Reactive Protein (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 two diabetes in first degree relatives 11. No informed consent from parents or legal guardians
Date of first enrolment	01/04/2007
Date of final enrolment	01/04/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre (AMC)

Amsterdam
1100 DD
Netherlands

Sponsor information

Diabetes Fonds Nederland (The Netherlands)
Research organisation

Stationsplein 139
Amersfoort
3818 LE
Netherlands

Email	info@diabetesfonds.nl
Website	http://www.diabetesfonds.nl/
"ROR"	https://ror.org/04ch2g225

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

26/08/2021: Proactive update review. No publications found. Search options exhausted.