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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00314717

Enrollment

Registered

2006-04-14

Start date

2006-04-30

Completion date

2007-04-30

Last updated

2011-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Brief summary

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.

Detailed description

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).

Interventions

BEHAVIORALControl diet

BEHAVIORALLow GI diet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Fasting serum glucose	Baseline and 4 weeks
A1c	Baseline and 4 weeks
Self-blood-glucose-monitoring results	daily until delivery

Secondary

Measure	Time frame
dosage and frequency of insulin	duration of pregnancy
ultrasound measurements (if available)	according to clinical practice
fasting lipids	Baseline and 4 weeks
fasting c-reactive protein	Baseline and 4 weeks
infant birth weight	at birth
maternal weight gain throughout pregnancy	weekly
infant plasma calcium	at birth
infant bilirubin at birth obtained via heel prick	at birth
birth complications	at birth
perceptions of educational materials	—
perceptions of diet treatments	—
infant blood glucose	at birth
number of individuals who receive insulin treatment while participating in the study	duration of pregnancy
latency to insulin requirement/ gestational age when prescribed insulin	duration of pregnancy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026