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

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00314717
• Other study ID #: Protocol reference 16929
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2006
• Last updated: June 20, 2011
• Start date: April 2006
• Est. completion date: April 2007

Study information

• Verified date: August 2007
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes
• Hyperglycemia

Intervention

Behavioral:
• Control diet

• Low GI diet

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract. 2011 Jan;91(1):15-22. doi: 10.1016/j.diabres.2010.09.002. Epub 2010 Nov 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting serum glucose		Baseline and 4 weeks
Primary	A1c		Baseline and 4 weeks
Primary	Self-blood-glucose-monitoring results		daily until delivery
Secondary	maternal weight gain throughout pregnancy		weekly
Secondary	number of individuals who receive insulin treatment while participating in the study		duration of pregnancy
Secondary	latency to insulin requirement/ gestational age when prescribed insulin		duration of pregnancy
Secondary	dosage and frequency of insulin		duration of pregnancy
Secondary	ultrasound measurements (if available)		according to clinical practice
Secondary	fasting lipids		Baseline and 4 weeks
Secondary	fasting c-reactive protein		Baseline and 4 weeks
Secondary	infant birth weight		at birth
Secondary	infant blood glucose		at birth
Secondary	infant plasma calcium		at birth
Secondary	infant bilirubin at birth obtained via heel prick		at birth
Secondary	birth complications		at birth
Secondary	perceptions of educational materials
Secondary	perceptions of diet treatments