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

Danone

Status

Terminated

Conditions

Gestational Diabetes Mellitus in Pregnancy

Treatments

Other: Standard breakfast according to ADA recommendations

Dietary Supplement: Nutritional product

Study type

Interventional

Funder types

Industry

Identifiers

NCT02225951

GDM.1.C/A

Details and patient eligibility

About

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.

Full 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.

Enrollment

3 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No 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