The Municipal Health Service The Hague and the LUMC are planning to conduct a study similar to the one in Pune in The Hague. In the start-up phase of this study we are preparing a pilot study in which we will study anthropometry and insulin…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints will be measures of neonatal anthropometry and insulin
resistance in South-Asian and indigenous Dutch neonates. Comparing these will
show if the *thin-fat* insulin resistant phenotype can be found among South
Asian neonates in The Hague. Other endpoints concern the feasibility and
utility of the methods that will be used in the main study.
Secondary outcome
The development of a food frequency questionnaire for pregnant South Asian
women
Background summary
The prevalence of type 2 diabetes is very high among South Asians in The Hague
and in other parts of the world. The causes of this high prevalence are
unclear. One of the proposed theories is the *fetal origins*-hypothesis, which
proposes that persistent metabolic and structural changes caused by fetal
undernutrition (due to maternal malnutrition) increase the risk of type 2
diabetes and cardiovascular disease. Nowadays there is much support and some
evidence for the idea that the high diabetes and high cardiovascular risk among
South Asians is related to fetal developmental issues. For example Indian
babies are among the smallest of the world and they are characterized by
truncal adiposity and hyperinsulinemia already at birth (*thin-fat Indian
baby*). Moreover, in India the results of the Pune Maternal Nutrition Study
showed that several micronutrients measured in maternal blood samples and
intake of micronutrient-rich foods were related to neonatal anthropometry. The
results of this study can be used to design new preventive measurements.
Study objective
The Municipal Health Service The Hague and the LUMC are planning to conduct a
study similar to the one in Pune in The Hague. In the start-up phase of this
study we are preparing a pilot study in which we will study anthropometry and
insulin resistance in South Asian and indigenous Dutch neonates to asses if the
thin-fat insulin resistant phenotype is prevalent in South Asian neonates in
The Hague. In this pilot study we will also test the feasibility and the
utility of the methods to be used in the main study.
Study design
a longitudinal observational study
Study burden and risks
- At 28 weeks of pregnancy women will be asked to fill in a questionnaire and
several measurements will be performed (length, weight, head circumference,
mid-upperarm circumference and the four skinfolds). The questionnaire will be
more extensive for South Asian women, because they will also have to fill in a
food frequency questionnaire. We estimate that filling in the questionnaire
will take about 30 minutes for the indigenous Dutch women and 60 minutes for
the South Asian women, and performing the physical measurements will take about
15 minutes.
- After delivery cord blood will be taken of women who deliver in the hospital.
This isn't painful for neither the mother nor the baby. It's proven to be safe
and is used frequently for for example bloodcell-donation.
- Within 72 hours after birth several measurements will be performed on the
neonate. Weight and length will be measured, as well as head, abdominal and
mid-upperarm circumference and the thickness of the subscapular and
triceps-skinfold. These measurements aren't painful and have no risks for the
baby. We expect that it will take about 15 minutes to perform these
measurements.
Thorbeckelaan 360
2564 BZ Den Haag
Nederland
Thorbeckelaan 360
2564 BZ Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
Surinamese Asian Indian pregnant women of whom both biological parents and the father of the baby are from Surinamese Asian Indian descent.
Indigenous Dutch pregnant women are eligible for inclusion if both biological parents and the father of the baby are indigenous Dutch.
Only neonates with a gestational age of minimal 32 weeks will be included.
Exclusion criteria
- women who expect multiple births (twins, triplets, etc)
- women under the age of 18 years
Design
Recruitment
metc-ldd@lumc.nl
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 | NL12684.098.06 |