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Completed

NCT Number: NCT00314717

The Effect of a Low Glycemic Index Diet on Blood Sugar Control in Women With Gestational Hyperglycemia

The purpose of the study is to see if a low glycemic index diet will reduce blood sugar levels in pregnant women with high blood sugar levels.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational 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–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

Women with gestational hyperglycemia, including women with gestational diabetes and impaired glucose tolerance of pregnancy, consuming a low glycemic index (GI) diet will experience better blood glucose control thereby decreasing the risk associated complication(s).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women with gestational hyperglycemia
  • age between 18 and 45 inclusive
  • willing and able to comply with protocol

Exclusion criteria

  • <18 or >45 years of age
  • other chronic or acute illness which affects carbohydrate metabolism
  • known multiple pregnancy
  • >34 weeks gestation
  • language barrier (no translator available)

Treatment and study plan

Control diet

Behavioral

Low GI diet

Behavioral

Primary outcomes

  1. Fasting serum glucose

    Time frame: Baseline and 4 weeks

  2. A1c

    Time frame: Baseline and 4 weeks

  3. Self-blood-glucose-monitoring results

    Time frame: daily until delivery

Secondary outcomes

  1. maternal weight gain throughout pregnancy

    Time frame: weekly

  2. number of individuals who receive insulin treatment while participating in the study

    Time frame: duration of pregnancy

  3. latency to insulin requirement/ gestational age when prescribed insulin

    Time frame: duration of pregnancy

  4. dosage and frequency of insulin

    Time frame: duration of pregnancy

  5. ultrasound measurements (if available)

    Time frame: according to clinical practice

  6. fasting lipids

    Time frame: Baseline and 4 weeks

  7. fasting c-reactive protein

    Time frame: Baseline and 4 weeks

  8. infant birth weight

    Time frame: at birth

  9. infant blood glucose

    Time frame: at birth

  10. infant plasma calcium

    Time frame: at birth

  11. infant bilirubin at birth obtained via heel prick

    Time frame: at birth

  12. birth complications

    Time frame: at birth

  13. perceptions of educational materials

  14. perceptions of diet treatments

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Registry information

Important dates

Study start
2006
Study completion
2007
First posted
Apr 14, 2006
Registry last updated
Jun 21, 2011

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.

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