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

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status

Terminated

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Nutritional product

Standard breakfast according to ADA recommendations

About this trial

This is an interventional other trial for Gestational Diabetes Mellitus in Pregnancy

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pregnant women, aged 18-40 years
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)]
Singleton pregnancy
Newly GDM diagnosed women between 24 to (the latest) 32 weeks of gestation;
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]
Willing and able to comply with the protocol
Signed informed consent

Exclusion Criteria:

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)
Currently on anti-diabetic therapy, for example on insulin or oral anti-diabetic medication
Already using a diabetes nutritional/dietary supplement (e.g. Glucerna®, Nutrient Diabetes®) within 4 weeks prior to signing informed consent
Known allergy or intolerance for any of the following ingredients; fish, milk, protein, lactose, fiber or soy
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.)
Currently or previously on special low/no carbohydrate diet (e.g. Atkin's diet) within 8 weeks prior to signing informed consent
Incapability to comply with study protocol or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Participation in other studies involving investigational or marketed products concomitantly or within 4 weeks prior signing informed consent

Sites / Locations

KK Women's and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Test group

Control Group

Arm Description

Nutritional product as breakfast.

Standard breakfast according to ADA recommendations for pregnant women diagnosed with Gestational Diabetes Mellitus.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02225951

First Posted

August 25, 2014

Last Updated

September 4, 2017

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Collaborators

Nutricia Research

1. Study Identification

Unique Protocol Identification Number

NCT02225951

Brief Title

Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus.

Acronym

GDM-MTT

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Terminated

Why Stopped

Current protocol is not optimal/feasible

Study Start Date

July 2014 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Collaborators

Nutricia Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gestational Diabetes Mellitus in Pregnancy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Active Comparator

Arm Description

Nutritional product as breakfast.

Arm Title

Control Group

Arm Type

Other

Arm Description

Standard breakfast according to ADA recommendations for pregnant women diagnosed with Gestational Diabetes Mellitus.

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutritional product

Intervention Type

Other

Intervention Name(s)

Standard breakfast according to ADA recommendations

Primary Outcome Measure Information:

Title

3-hr postprandial glucose response

Description

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

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pregnant women, aged 18-40 years 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)] Singleton pregnancy Newly GDM diagnosed women between 24 to (the latest) 32 weeks of gestation; 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] Willing and able to comply with the protocol Signed informed consent Exclusion Criteria: 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) Currently on anti-diabetic therapy, for example on insulin or oral anti-diabetic medication Already using a diabetes nutritional/dietary supplement (e.g. Glucerna®, Nutrient Diabetes®) within 4 weeks prior to signing informed consent Known allergy or intolerance for any of the following ingredients; fish, milk, protein, lactose, fiber or soy 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.) Currently or previously on special low/no carbohydrate diet (e.g. Atkin's diet) within 8 weeks prior to signing informed consent Incapability to comply with study protocol or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements Participation in other studies involving investigational or marketed products concomitantly or within 4 weeks prior signing informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kok Hian Tan, MBBS

Organizational Affiliation

KKH

Official's Role

Principal Investigator

Facility Information:

Facility Name

KK Women's and Children's Hospital

City

Singapore

ZIP/Postal Code

229899

Country

Singapore

12. IPD Sharing Statement

Learn more about this trial

Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus.

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