Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus. (GDM-MTT)

A Randomised, Controlled, Open-label Trial to Investigate the Effect of a New Nutritional Supplement on Postprandial Glucose Response in Women Diagnosed With Gestational Diabetes Mellitus.

This study is initiated to investigate the effect of a nutritional product on the 3-hr postprandial glucose response compared to a control standard breakfast at baseline and after 4 weeks of intervention.

Study Overview

• Status: Terminated
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Dietary supplement: Nutritional product; Other: Standard breakfast according to ADA recommendations

Detailed Description

The primary objective of the study is to investigate the effect of study product on the 3-hour postprandial glucose response compared to a controlled standard breakfast at baseline and after 4 weeks of intervention. Secondary objectives include investigation on the effect of the product compared to a control standard breakfast to the 3-hr postprandial insulin response, postprandial peak and delta peak concentration of glucose and insulin, fasting concentration of glucose and insulin, and insulin resistance as calculated by the HOMA index. The study also aims to measure compliance, study product intake and appreciation, safety and tolerance to study product, as well as satiety, daily energy and nutrient intake.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pregnant women, aged 18-40 years
2. 18.5 kg/m2 < pre-pregnancy BMI < 27.5 kg/m2 [representing low to moderate risk category, adapted from WHO expert panel recommendation on BMI categories for determining public health and clinical action (REF: Lancet, 2004)]
3. Singleton pregnancy
4. Newly GDM diagnosed women between 24 to (the latest) 32 weeks of gestation;

5. Diagnosed GDM according to either:

   • World Health Organization (WHO) criteria if one or more glucose values equal to or exceed these threshold values [75g Oral Glucose Tolerance Test: fasting 126 mg/dl; 2-h 140 mg/dl] or
   • American Diabetic Association (ADA) criteria if two or more glucose values equal to or exceed these threshold values [100g Oral Glucose Tolerance Test: fasting 95 mg/dl; 1-h 180 mg/dl; 2-h 155 mg/dl, 3-h 140/dl]
6. Willing and able to comply with the protocol
7. Signed informed consent

Exclusion Criteria:

1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosaemia, hyperemesis)
2. Currently on anti-diabetic therapy, for example on insulin or oral anti-diabetic medication
3. Already using a diabetes nutritional/dietary supplement (e.g. Glucerna®, Nutrient Diabetes®) within 4 weeks prior to signing informed consent
4. Known allergy or intolerance for any of the following ingredients; fish, milk, protein, lactose, fiber or soy
5. Any significant medical condition, other than GDM, that might interfere with the study or known to affect intra-uterine growth (e.g. Type 1 Diabetes, Type 2 Diabetes Mellitus, Crohn's disease, HIV/AIDS, liver disease, kidney disease etc.)
6. Currently or previously on special low/no carbohydrate diet (e.g. Atkin's diet) within 8 weeks prior to signing informed consent
7. Incapability to comply with study protocol or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
8. Participation in other studies involving investigational or marketed products concomitantly or within 4 weeks prior signing informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Test group; Nutritional product as breakfast.	Dietary supplement: Nutritional product
OTHER: Control Group; Standard breakfast according to ADA recommendations for pregnant women diagnosed with Gestational Diabetes Mellitus.	Other: Standard breakfast according to ADA recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-hr postprandial glucose response	To investigate the effect of a nutritional product on the 3-hr postprandial glucose response compared to a control standard breakfast at baseline and after 4 weeks of intervention	28 days

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: Nutricia Research
• Investigators: Principal Investigator: Kok Hian Tan, MBBS, KKH

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: August 25, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (ESTIMATE): August 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: GDM.1.C/A