Condition category
Pregnancy and Childbirth
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
16/03/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof H P Sauerwein

ORCID ID

Contact details

Academic Medical Centre (AMC)
Department of Endocrinology and Metabolism
F5-170
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 3061
h.p.sauerwein@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Approval received from the Central Committee on Research inv. Human Subjects on the 30th January 2006 (ref: P05.1488C).

Study design

Observational study

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2007

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Neonate

Gender

Not Specified

Target number of participants

16

Participant 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

Recruitment start date

01/04/2007

Recruitment end date

01/04/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre (AMC)
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Diabetes Fonds Nederland (The Netherlands)

Sponsor details

Stationsplein 139
Amersfoort
3818 LE
Netherlands
info@diabetesfonds.nl

Sponsor type

Research organisation

Website

http://www.diabetesfonds.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes