GRAPE-GDM Prospective Comperative Trial - Grape Juice as a Replacement Drink for Gestational Diabetes Screening

NCT07323901 | Enrolling By Invitation

• 1 other identifier: BNZ-0122-24
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Study Type: Observational, prospective, multicenter comparative study Primary Purpose: The goal of this study is to evaluate whether grape juice can serve as an effective alternative to the standard 50g glucola drink for gestational diabetes screening in pregnant individuals at 24-28 weeks of gestation. Main Questions: Can an alternative glucose-loading drink (grape juice) provide comparable blood glucose measurements to the standard GCT? Does grape juice improve patient satisfaction and compliance with gestational diabetes screening? Comparison Group: Researchers will compare the standard GCT (50g glucola drink) with the alternative GCT (500 ml grape juice containing 50g sugar). Each participant will undergo both tests, serving as her own control, to assess differences in glucose measurements and patient preferences. Participant Tasks: Participants will: \- Undergo two glucose challenge tests (GCT): Standard GCT (50g glucola) at their health maintenance organization (HMO) or hospital. Alternative GCT (500 ml grape juice) during a scheduled visit or hospitalization.

• Have blood drawn one hour after each test for glucose measurement.
• Complete a questionnaire assessing satisfaction and preference between the two methods.
• Provide follow-up information if they require additional testing (e.g., 100g OGTT).

Conditions

Pregnancy - Prenatal Testing

Outcome Measures

Primary Outcomes (1)

• Blood glucose concentration after test beverage

  Venous plasma glucose ( measured at 60 minutes after each beverage

  one hour from injestion of the drink

Secondary Outcomes (3)

• Participant satisfaction with glucose drink

  One hour after ingestion of the glucose drink.

• Participant preference for glucose challenge test drink

  One hour after ingestion of the glucose drink.

• Adverse events following glucose drink ingestion

  One hour after ingestion of the glucose drink.

Other Outcomes (3)

• Gestational age at birth

  At delivery

• Neonatal birth weight

  At birth

• Mode of delivery

  At delivery

Study Arms (1)

grape juice

EXPERIMENTAL

Participants: Each participant will undergo both the standard GCT and an alternative GCT using 500 ml of grape juice (containing 50g of sugar). Control Group: Each participant serves as her own control by completing both tests in a randomized order.

Other: Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load.

Interventions

Participants will consume 500 ml of commercially available grape juice which contains 50g of sugar, serving as an alternative glucose load. OTHER

This study investigates a non-carbonated, natural beverage (grape juice) as an alternative glucose-loading method for gestational diabetes screening. Unlike other studies that have explored alternative carbohydrate sources such as jelly beans or gummy candies-which require chewing and may impact dental health-our study focuses on a readily available liquid alternative that closely mimics the glucose absorption kinetics of the standard 50g glucola drink.

grape juice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant individuals scheduled for routine GCT at 24-28 weeks. Well-dated pregnancy (confirmed first-trimester ultrasound). Willingness to comply with study protocol.

You may not qualify if:

• High-risk individuals requiring direct 100g OGTT (e.g., prior GDM, BMI \>40, PCOS).
• Intolerance to the alternative drink. Gastrointestinal conditions affecting glucose absorption such as active bowel disiease.
• Recent corticosteroid administration for fetal lung maturity after standard GCT.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

Location

MeSH Terms

Interventions

Sugars

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: January 7, 2026
• Study Start: February 19, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: January 7, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)