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DIAgnosing GDM usiNg Oral Sugar InStead

NCT05115188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-12-29

No results posted yet for this study

Summary

The purpose of this study is to compare the positive and negative effects of Dex4® tablets, as an alternative form of fast acting carbohydrate, compared to the current standard diagnostic test, glucose beverage. The investigators hypothesis that because of their availability in solid, chewable form, variety of flavours and lack of carbonation, Dex4® tablets may result in fewer side effects than glucose beverage and provide an equivalent carbohydrate challenge for diagnosis of gestational diabetes.

Conditions

  • Diabetes, Gestational

Interventions

DIETARY_SUPPLEMENT

Dex4/ dextrose

Participants will be asked to ingest 21 Dex4® tablets and no more than 300ml of water within 5 minutes. Blood draws will be performed at fasting (before ingesting the dextrose monohydrate tablets), as well as 1 hour after (+/- 15 minutes) and 2 hours (+/- 15 minutes) after ingesting the dextrose monohydrate tablets.

DIETARY_SUPPLEMENT

Glucose beverage

For the 2 hour oral glucose tolerance test (OGTT), women fast for 8 hours and then consume 75g of glucose beverage, and serum glucose levels are taken at fasting, 1 and 2 hours after drinking the glucose beverage. The 75g OGTT is the gold standard and is performed for GDM diagnosis.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05115188 on ClinicalTrials.gov