Skip to main content
OpenTrials
Completed

NCT Number: NCT01105455

The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Pregnant Women at Risk for Gestational Diabetes

Gestational diabetes mellitus (GDM) is a condition in which high blood sugar levels occur during pregnancy. GDM increases the risk of medical complications during pregnancy which may harm the mother and her baby. Since treating GDM to reduce blood sugar reduces the risk of harm, all pregnant women are screened for GDM using a glucose challenge test (GCT). We think that a diet containing low glycemic index foods could help keep blood sugar levels normal during pregnancy and therefore prevent GDM. Thus, the purpose of this study is to see if a diet containing low glycemic index foods will reduced blood sugar after the GCT and reduce the prevalence of GDM in women at high risk for the development of GDM.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes, Gestational Diabetes Mellitus Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mt Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Attending Mt. Sinai Maternal Fetal Medicine Unit
  • Any ONE of: body mass index >=25 kg/m^2
  • OR age >=35 years
  • OR high risk ethnicity (Asian, South Asian, Hispanic, African, Aboriginal)

Exclusion criteria

  • Have pre-existing diabetes (type 1 or type 2) before becoming pregnant
  • Acute or chronic illness which may affect carbohydrate metabolism
  • Language/literacy barriers which cannot be overcome via available resources
  • >16 weeks gestation

Treatment and study plan

Nutrition education

Other

Group nutrition classes supplemented by handouts and provision of key study foods.

Primary outcomes

  1. Serum glucose concentration 1hr after glucose challenge test

    Time frame: 26 weeks gestation

Secondary outcomes

  1. GCT outcome

    Time frame: 26 weeks gestation

    ie. normal, borderline, abnormal

  2. GDM outcome

    Time frame: 26 weeks gestation

    Presence or absence of gestational diabetes

  3. Maternal weight

    Time frame: At EACH of the following times: 12, 16, 20, 24, 28, 32, 36 and 40 weeks gestation

  4. Mode of delivery

    Time frame: At time of birth of baby

    Normal or cesarean section

  5. Presence of birth trauma

    Time frame: At time of birth of baby

  6. Weight of baby

    Time frame: At time of birth of baby

  7. Presence of macrosomia

    Time frame: At time of birth of baby

  8. presence of large for gestational age baby

    Time frame: At time of birth of baby

  9. Presence of small for gestational age baby

    Time frame: At time of birth of baby

  10. food frequency questionnaire

    Time frame: at 12 weeks and 26 weeks gestation

  11. Acceptability of study foods

    Time frame: 26 weeks gestation

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 16, 2010
Registry last updated
Mar 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.