Status:
TERMINATED
Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus.
Lead Sponsor:
Danone Asia Pacific Holdings Pte, Ltd.
Collaborating Sponsors:
Nutricia Research
Conditions:
Gestational Diabetes Mellitus in Pregnancy
Eligibility:
All Genders
18-40 years
Phase:
NA
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 intervent...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT02225951
Start Date
July 1 2014
End Date
September 1 2014
Last Update
September 7 2017
Active Locations (1)
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1
KK Women's and Children's Hospital
Singapore, Singapore, 229899