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

NCT02225951 | Terminated

• 1 other identifier: GDM.1.C/A
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Test group

ACTIVE COMPARATOR

Nutritional product as breakfast.

Dietary Supplement: Nutritional product

Control Group

OTHER

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

Other: Standard breakfast according to ADA recommendations

Interventions

Nutritional product DIETARY_SUPPLEMENT

Test group

Standard breakfast according to ADA recommendations OTHER

Control Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women, aged 18-40 years
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• Nutricia Research: collaborator

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Study Officials

• Kok Hian Tan, MBBS

  KKH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 26, 2014
• Study Start: July 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 7, 2017

Record last verified: 2017-09

Locations

SG (1)