Gestational DiabetesNCT03749889
Low Carb vs Normal Carb in Pregnancy
A study testing 100 g carbs and MyPlate in people with Gestational Diabetes, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- 100 g carbs and MyPlate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2018to 5 Aug 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 - 40 years old
- BMI > 30 and/or history of gestational diabetes mellitus
- Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets, etc.)
- Newborns of current participants
Who cannot join
- Diabetes (types 1 and 2)
- History of major chronic disease or blood clotting disorders (e.g., cancer, heart disease, kidney disease, hypertension)
- Known fetal anomaly
- History of eating disorders
- Current use of medications that affect appetite or insulin secretion/sensitivity (e.g. stimulants)
- Current use of illegal substances, antipsychotic or opioid substitution medications, alcohol, or tobacco
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bump to Baby Study
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.
- Conditions
- Gestational Diabetes
- Being tested
- 100 g carbs, MyPlate
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100 g carbsOther
Participants will be assigned a diet of 100g carbs max for the day
MyPlateOther
40-65% of daily intake is from carbohydrates
| Study group | Role | What they receive |
|---|---|---|
| 100 g carbs | Experimental | 100 grams of carbohydrate allowance for the day Receives: Other: 100 g carbs |
| MyPlate | Active comparator | Carbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs. Receives: Other: MyPlate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Outcome Questionnaire
Upon delivery of the baby, a birth outcome questionnaire will be collected which includes questions about the delivery and birth of the baby and a question about gestational diabetes. The answer to gestational diabetes or not will be the measure for the outcome.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start4 Sep 2018
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
Why it stopped: Unable to provide OBGYN to assist with study for IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Ling Kong, State University of New York at Buffalo
- Investigators
- Kai Ling Kong, PhD, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749889
- Sponsor's protocol ID
- 00002745
- Status last verified
- Sep 2019
- First submitted
- 28 Aug 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bump to Baby Study
- ClinicalTrials.gov ID
- NCT03749889
- Acronym / sponsor ID
- 00002745
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to provide OBGYN to assist with study for IRB approval
- Enrolment
- 11 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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.
The overall purpose of this intervention study is to examine whether low-carbohydrate dietary intervention will prevent the development of gestational diabetes mellitus (GDM) in high-risk pregnant women. The results of this study should help further our understanding of how pregnant women can help prevent gestational diabetes mellitus. We hypothesize that a lower carbohydrate diet will prevent the development of GDM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 g carbs | Experimental | Other: 100 g carbs100 grams of carbohydrate allowance for the day |
| MyPlate | Active comparator | Other: MyPlateCarbohydrate suggestions based on standard MyPlate. 45-65% kcal intake from carbs. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 - 40 years old
- BMI > 30 and/or history of gestational diabetes mellitus
- Currently in first trimester of pregnancy with single fetus (e.g. not twins, triplets, etc.)
- Newborns of current participants
Key exclusion criteria (6 listed)
- Diabetes (types 1 and 2)
- History of major chronic disease or blood clotting disorders (e.g., cancer, heart disease, kidney disease, hypertension)
- Known fetal anomaly
- History of eating disorders
- Current use of medications that affect appetite or insulin secretion/sensitivity (e.g. stimulants)
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 |
|---|---|---|
| 100 g carbsParticipants will be assigned a diet of 100g carbs max for the day | Other | 100 g carbs |
| MyPlate40-65% of daily intake is from carbohydrates | Other | MyPlate |
Primary outcome
Birth Outcome Questionnaire
Time frame: 24 months
Upon delivery of the baby, a birth outcome questionnaire will be collected which includes questions about the delivery and birth of the baby and a question about gestational diabetes. The answer to gestational diabetes or not will be the measure for the outcome.
Results and safety
The study was stopped early (reason given: Unable to provide OBGYN to assist with study for IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
Kai Ling Kong, PhD principal investigator
SUNY Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100 g carbs and MyPlate in people with Gestational Diabetes, run by State University of New York at Buffalo at 1 site in United States.
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 4 inclusion and 6 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 18 Sep 2019. 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 United States. 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: Unable to provide OBGYN to assist with study for IRB approval). 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?
Birth Outcome Questionnaire (time frame: 24 months). 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 18 Sep 2019.