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Effects of Chewing Gum on Glycaemic Control in Women With Gestational Diabetes

NCT03961542 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-05-23

No results posted yet for this study

Summary

This study aims to assess the impact of enhanced chewing on glycaemic control in females with newly diagnosed GDM. It is hypothesised, that a fixed amount of gum chewed for 20 minutes before starting each meal could improve hyperglycaemia. The impact of chewing on postprandial capillary blood glucose (measured at one hour after breakfast, lunch and dinner) is determined as the primary outcome of this study.

Differences in fasting glucose and longitudinal changes over the study period should be additionally examined.

Conditions

  • Gestational Diabetes Mellitus in Pregnancy

Interventions

OTHER

Chewing

Eligible patients are randomized to receive either routine care (control group) or routine care in addition to a chewing gum intervention for five days (beginning with the second study day, i.e. the day after baseline examination): sugar-free, fruit or mint flavoured gum chewed three times daily for 20 minutes before each meal. Routine care includes standard dietary and lifestyle advice for 30 minutes following our local recommendations as well as an advice on capillary blood glucose measurement (fasting as well as 1h after starting each meal). Capillary blood glucose profiles are reevaluated seven days after starting the blood glucose monitoring. Study visits will be scheduled at screening (visit 1, where eligible patients were randomized) as well as seven days later (visit 2).

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-22
Primary Completion
2018-11-30
Completion
2018-12-10

Countries

  • Austria

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 NCT03961542 on ClinicalTrials.gov