Gestational Diabetes Mellitus in PregnancyGDM-MTTNCT02225951
Meal Tolerance Trial in Pregnant Women Diagnosed With Gestational Diabetes Mellitus.
A study testing Nutritional product and Standard breakfast according to ADA recommendations in people with Gestational Diabetes Mellitus in Pregnancy, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Nutritional product and Standard breakfast according to ADA recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2014to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- Nutritional product, Standard breakfast according to ADA recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional productDietary supplement
Standard breakfast according to ADA recommendationsOther
| Study group | Role | What they receive |
|---|---|---|
| Test group | Active comparator | Nutritional product as breakfast. Receives: Dietary Supplement: Nutritional product |
| Control Group | Other | Standard breakfast according to ADA recommendations for pregnant women diagnosed with Gestational Diabetes Mellitus. Receives: Other: Standard breakfast according to ADA recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2014
- Study completionSep 2014
Why it stopped: Current protocol is not optimal/feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutricia Research
- Responsible party
- Sponsor
- Investigators
- Kok Hian Tan, MBBS, Principal investigator, KKH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225951
- Sponsor's protocol ID
- GDM.1.C/A
- Acronym
- GDM-MTT
- Status last verified
- Sep 2017
- First submitted
- 25 Aug 2014
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02225951
- Acronym / sponsor ID
- GDM-MTT / GDM.1.C/A
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Current protocol is not optimal/feasible
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nutricia Research
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Active comparator | Dietary Supplement: Nutritional productNutritional product as breakfast. |
| Control Group | Other | Other: Standard breakfast according to ADA recommendationsStandard breakfast according to ADA recommendations for pregnant women diagnosed with Gestational Diabetes Mellitus. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional product | Dietary supplement | Test group |
| Standard breakfast according to ADA recommendations | Other | Control Group |
Primary outcome
3-hr postprandial glucose response
Time frame: 28 days
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
Results and safety
The study was stopped early (reason given: Current protocol is not optimal/feasible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kok Hian Tan, MBBS principal investigator
KKH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional product and Standard breakfast according to ADA recommendations in people with Gestational Diabetes Mellitus in Pregnancy, run by Danone Asia Pacific Holdings Pte, Ltd. at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Current protocol is not optimal/feasible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-hr postprandial glucose response (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.