← Back to Search

Carbohydrate

2-hr OGTT with Dex4® tablets for Gestational Diabetes (DIAGNOSIS Trial)

Phase 2

Recruiting

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 2 hours after glucose ingestion

Awards & highlights

DIAGNOSIS Trial Summary

This trial tests the effectiveness of Dex4® tablets in diagnosing gestational diabetes, with fewer side effects than current glucose beverage tests.

Who is the study for?

This trial is for pregnant women who have consented to participate, are carrying one baby, and had a specific range of blood sugar levels after a glucose challenge test. It's designed to find a better way to diagnose gestational diabetes.Check my eligibility

What is being tested?

The study compares the effects of Dex4® tablets (a chewable form of sugar) with the standard glucose beverage used in diagnosing gestational diabetes. The goal is to see if Dex4® causes fewer side effects and provides an equivalent diagnostic test.See study design

What are the potential side effects?

Potential side effects may include discomfort from consuming high-sugar content products like nausea or bloating. However, Dex4® tablets might lead to fewer issues due to their solid form and variety of flavors.

DIAGNOSIS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am female.

DIAGNOSIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 2 hours after glucose ingestion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 2 hours after glucose ingestion

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 hours after glucose ingestion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Glucose values in the oral glucose tolerance test

Secondary outcome measures

Adverse effect - dizziness (qualitative measurement)

Adverse effect - headache (qualitative measurement)

Nausea

+4 more

DIAGNOSIS Trial Design

2Treatment groups

Experimental Treatment

Group I: 2-hr OGTT with glucose beverageExperimental Treatment1 Intervention

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.

Group II: 2-hr OGTT with Dex4® tabletsExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glucose beverage

2017

N/A

~20

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,580 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators still enrolling participants in this research project?

"Affirmative. Data accessible through clinicaltrials.gov indicates that this medical experiment, initially posted on October 1st 2022, is actively recruiting participants. This research requires 42 individuals to be sourced from a single site."

Answered by AI

How many individuals have enrolled in this medical study?

"Yes, the data on clinicaltrials.gov affirms that this medical experiment is actively recruiting patients; it was first posted in October 1st 2022 and updated last December 11th 2023. The study requires 42 participants to be enrolled at one singular site."

Answered by AI

What evidence exists to suggest that two-hour oral glucose tolerance test with Dex4® tablets is safe?

"There is evidence that 2-hr OGTT with Dex4® tablets is not dangerous, thus it was awarded a score of 2. Nonetheless, there are no clinical studies demonstrating its efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

DIAgnosing GDM usiNg Oral Sugar InStead

2022. "DIAgnosing GDM usiNg Oral Sugar InStead". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05115188.