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

NCT03961542 | Completed

• 1 other identifier: 20171218
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• blood glucose measurements after with or without chewing

  1hour postprandial capillary blood glucose measurements

  for one week (7 Days) after breakfast, lunch and dinner

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Chewing

Control Group

NO INTERVENTION

Participants will be randomized to either treatment (chewing gum) or control group (routine care) in a 1:1 ratio. The minimisation method \[Pocock 1975\] will be used to minimize the imbalance between the groups according to the preconceptional overweight/obesity status with three strata: i. normal weight (i.e. BMI below 25 kg/m²); ii. overweight (BMI 26 - 30 kg/m²); iii. obesity (BMI and above 30 kg/m²).

Interventions

Chewing OTHER

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).

Also known as: chewing, gum, blood glucose

Intervention Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Preconceptional overt diabetes (such as type 1 or type 2 diabetes)
• History of bariatric surgery or surgeries that induce malabsorption
• HIV- or hepatitis infection
• Decreased liver or kidney function (before pregnancy)
• history of malignant disorders
• Abuse of toxic substances
• Use of systemic steroids
• Active smoking status during pregnancy
• Multiple pregnancy
• Ovulatory drugs and in-vitro fertilisation

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Christian Göbl

Vienna, 1090, Austria

Location

Related Publications (1)

• Yerlikaya-Schatten G, Trimmal L, Rosicky I, Husslein P, Schatten C, Eppel D, Eppel W, Tura A, Gobl CS. Effects of gum chewing on glycaemic control in women with gestational diabetes mellitus: A randomized controlled trial. Impact of chewing on hyperglycaemia in women with GDM. Eur J Obstet Gynecol Reprod Biol. 2020 Apr;247:61-65. doi: 10.1016/j.ejogrb.2020.02.003. Epub 2020 Feb 9.

  PMID: 32070847 DERIVED

MeSH Terms

Interventions

Mastication; Chewing Gum; Blood Glucose

Intervention Hierarchy (Ancestors)

Eating; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Food and Beverages; Glucose; Hexoses; Monosaccharides; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 20, 2019
• First Posted: May 23, 2019
• Study Start: December 22, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 10, 2018
• Last Updated: May 23, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)