Gestational DiabetesHINT-GDMNCT04187521
Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
A study testing Meal A and Meal B in people with Gestational Diabetes, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Meal A and Meal B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Feb 2020to 30 Nov 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Diagnosis of gestational diabetes
Who cannot join
- Known diabetes mellitus that preceded pregnancy
- Food allergies to components of the test meals
- Use of medications known to affect glucose tolerance
- Have extensive skin changes or diseases making CGM sensor use problematic
- Demonstrated allergy to CGM adhesive
- Inability to adhere to the swimming and bathing instructions
Show all 10Show fewer
- Plan to have MRI, CT scan, X Ray or diathermy (heat treatment) during the 7-day CGM study period
- Inability to adhere to Vitamin C guidelines during study period (using more than 500 mg of Vitamin C/day which could interfere with the CGM)
- Use of medications known to affect glucose tolerance
- In the opinion of the principal investigator (PI), demonstrate any other factor likely to limit compliance with the protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
The hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.
Read the detailed description
Diabetes mellitus can be classified based on impairments in two different physiologic parameters, insulin secretion and insulin sensitivity. The investigator involved in this trial has previously defined GDM subtypes based on underlying physiology and demonstrated that women with GDM and predominant sensitivity defects have an elevated risk of adverse pregnancy outcomes, while women with predominant secretion defects do not appear to carry the same risk. This supports the idea that not all gestational diabetes is the same. Ideal treatment strategies may differ between GDM subtypes. In this trial, investigators will evaluate the postprandial glycemic response to two test meals with different macronutrient content in different GDM physiologic subtypes. Two test meals with different macronutrient proportions have been designed by research dieticians. Participants will eat test meals at home for breakfast in a randomized order after an overnight fast. Participants will complete food and blood sugar diaries, and will wear a continuous glucose monitor, which will measure postprandial glucose.
- Conditions
- Gestational Diabetes
- Being tested
- Meal A, Meal B
- Keywords
- gestational diabetes, pregnancy, diet, nutrition
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal AOther
A breakfast meal with a specific macronutrient proportions.
Meal BOther
A breakfast meal with a specific macronutrient proportions.
| Study group | Role | What they receive |
|---|---|---|
| Sensitivity defect | Other | Participants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion. Receives: Other: Meal A; Other: Meal B |
| Secretory defect | Other | Participants defined as having abnormal insulin secretion without a defect in insulin sensitivity. Receives: Other: Meal A; Other: Meal B |
| Unclassified | Other | Participants who cannot be classified as having abnormal insulin secretion or abnormal insulin sensitivity or who have both abnormal insulin sensitivity and abnormal insulin secretion. Receives: Other: Meal A; Other: Meal B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak blood glucose following test meal (CGM)
Peak postprandial blood glucose after test meal assessed by continuous glucose monitor
Measured: 15 mins - 3 hours
Secondary outcomes (18)
One-hour post prandial blood glucose following test meal (SMBG)
1 hour postprandial blood glucose after test meal on day 2 and day 3 assessed by glucometer
Measured: 1 hour
Glucose area under the curve following test meal (CGM)
Area under the curve of CGM measured glucose from the start of the test meal to three hours after the test meal is started
Measured: 3 hours
Meal taste
Palatability of the test meals measured using a visual analog scale
Measured: 1 hour
Meal satiety
Satiety following meal measured using a visual analog scale
Measured: 3 hours
Meal completion
Percent of test meal finished assessed by photo of completed meal
Measured: 1 hour
Peak blood glucose following lunch on day of test meal (CGM)
Peak postprandial blood glucose after lunch on days of test meals assessed by CGM
Measured: 15 mins - 3 hours
One-hour post prandial blood glucose following lunch on day of test meal (SMBG)
1 hour postprandial blood glucose after lunch on days of test meals assessed by glucometer
Measured: 1 hour
Carbohydrate content of lunch after test meal
Carbohydrate content (grams) of lunch meal following the test meal
Measured: 6 hours
Calorie content of lunch after test meal
Calorie content of lunch meal following the test meal
Measured: 6 hours
Peak blood glucose following dinner on day of test meals (CGM)
Peak postprandial blood glucose after dinner on day of test meal assessed by CGM
Measured: 15 mins - 3 hours
One-hour postprandial blood glucose following dinner on day of test meal (SMBG)
1 hour postprandial blood glucose after dinner on day of test meal assessed by glucometer
Measured: 1 hour
Carbohydrate content of dinner after test meal
Carbohydrate content (grams) of dinner meal following the test meal
Measured: 6 hours
Calorie content of dinner after test meal
Calorie content of dinner meal following the test meal
Measured: 6 hours
Mean blood glucose
Mean blood glucose on the day of the test meal assessed by CGM
Measured: 24 hours
Time in target range
Length of time at which the patient's BG are within goal range (65-140 mg/dl) on the day of test meal assessed by CGM
Measured: 24 hours
Time above target range
Length of time at which the patient's BG is >140 mg/dl on the day of test meals assessed by CGM
Measured: 24 hours
Time below target range
Length of time at which the patient's BG is <65 mg/dl on the day of test meals assessed by CGM
Measured: 24 hours
Total caloric intake on the days of test meals
Total calorie intake on the day that the test meal is consumed
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start10 Feb 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camille Elise Powe,M.D., Massachusetts General Hospital
- Investigators
- Camille E Powe, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187521
- Sponsor's protocol ID
- 2019p002395
- Other IDs
- 74256
- Acronym
- HINT-GDM
- Status last verified
- May 2026
- First submitted
- 3 Dec 2019
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Powe CE, Allard C, Battista MC, Doyon M, Bouchard L, Ecker JL, Perron P, Florez JC, Thadhani R, Hivert MF. Heterogeneous Contribution of Insulin Sensitivity and Secretion Defects to Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1052-5. doi: 10.2337/dc15-2672. Epub 2016 May 13.
PubMed 27208340Rosenberg EA, Thaweethai T, Soria-Contreras DC, James K, Kelty E, Azevedo R, Lassey S, Nelson S, Hsu S, Garry JL, Seely EW, Powe CE. Impact of fat and protein on postprandial glycemia in gestational diabetes: A randomized pilot crossover trial. Pregnancy (Hoboken). 2025 Dec 12;2(1):e70182. doi: 10.1002/pmf2.70182. eCollection 2026 Jan.
PubMed 42597028
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04187521
- Acronym / sponsor ID
- HINT-GDM / 2019p002395
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, pregnancy, diet, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Dec 2019 (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 hypothesis for this study is that women with different physiologic subtypes of gestational diabetes (GDM) (insulin secretion deficit vs. insulin sensitivity deficit) will differ in their glycemic responses to meals with different portions of dietary macronutrients. Investigators will determine GDM subtype based on glucose and insulin levels taken at multiple time points during an oral glucose tolerance test. Participants will consume two meals with different macronutrient content while wearing a continuous glucose monitor which will allow investigators to assess the glycemic response to the meals.
Detailed description
Diabetes mellitus can be classified based on impairments in two different physiologic parameters, insulin secretion and insulin sensitivity. The investigator involved in this trial has previously defined GDM subtypes based on underlying physiology and demonstrated that women with GDM and predominant sensitivity defects have an elevated risk of adverse pregnancy outcomes, while women with predominant secretion defects do not appear to carry the same risk. This supports the idea that not all gestational diabetes is the same. Ideal treatment strategies may differ between GDM subtypes. In this trial, investigators will evaluate the postprandial glycemic response to two test meals with different macronutrient content in different GDM physiologic subtypes. Two test meals with different macronutrient proportions have been designed by research dieticians. Participants will eat test meals at home for breakfast in a randomized order after an overnight fast. Participants will complete food and blood sugar diaries, and will wear a continuous glucose monitor, which will measure postprandial glucose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sensitivity defect | Other | Other: Meal A, Other: Meal BParticipants defined as having abnormal insulin sensitivity without an absolute defect in insulin secretion. |
| Secretory defect | Other | Other: Meal A, Other: Meal BParticipants defined as having abnormal insulin secretion without a defect in insulin sensitivity. |
| Unclassified | Other | Other: Meal A, Other: Meal BParticipants who cannot be classified as having abnormal insulin secretion or abnormal insulin sensitivity or who have both abnormal insulin sensitivity and abnormal insulin secretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Diagnosis of gestational diabetes
Key exclusion criteria (10 listed)
- Known diabetes mellitus that preceded pregnancy
- Food allergies to components of the test meals
- Use of medications known to affect glucose tolerance
- Have extensive skin changes or diseases making CGM sensor use problematic
- Demonstrated allergy to CGM adhesive
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 |
|---|---|---|
| Meal AA breakfast meal with a specific macronutrient proportions. | Other | Secretory defect, Sensitivity defect, Unclassified |
| Meal BA breakfast meal with a specific macronutrient proportions. | Other | Secretory defect, Sensitivity defect, Unclassified |
Primary outcome
Peak blood glucose following test meal (CGM)
Time frame: 15 mins - 3 hours
Peak postprandial blood glucose after test meal assessed by continuous glucose monitor
18 secondary outcomes
One-hour post prandial blood glucose following test meal (SMBG)
Time frame: 1 hour
Glucose area under the curve following test meal (CGM)
Time frame: 3 hours
Meal taste
Time frame: 1 hour
Meal satiety
Time frame: 3 hours
Meal completion
Time frame: 1 hour
Peak blood glucose following lunch on day of test meal (CGM)
Time frame: 15 mins - 3 hours
One-hour post prandial blood glucose following lunch on day of test meal (SMBG)
Time frame: 1 hour
Carbohydrate content of lunch after test meal
Time frame: 6 hours
Calorie content of lunch after test meal
Time frame: 6 hours
Peak blood glucose following dinner on day of test meals (CGM)
Time frame: 15 mins - 3 hours
One-hour postprandial blood glucose following dinner on day of test meal (SMBG)
Time frame: 1 hour
Carbohydrate content of dinner after test meal
Time frame: 6 hours
Calorie content of dinner after test meal
Time frame: 6 hours
Mean blood glucose
Time frame: 24 hours
Time in target range
Time frame: 24 hours
Time above target range
Time frame: 24 hours
Time below target range
Time frame: 24 hours
Total caloric intake on the days of test meals
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 27208340Powe CE, Allard C, Battista MC, Doyon M, Bouchard L, Ecker JL, Perron P, Florez JC, Thadhani R, Hivert MF. Heterogeneous Contribution of Insulin Sensitivity and Secretion Defects to Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1052-5. doi: 10.2337/dc15-2672. Epub 2016 May 13.
- Derived from this study: PubMed 42597028Rosenberg EA, Thaweethai T, Soria-Contreras DC, James K, Kelty E, Azevedo R, Lassey S, Nelson S, Hsu S, Garry JL, Seely EW, Powe CE. Impact of fat and protein on postprandial glycemia in gestational diabetes: A randomized pilot crossover trial. Pregnancy (Hoboken). 2025 Dec 12;2(1):e70182. doi: 10.1002/pmf2.70182. eCollection 2026 Jan.
- Individual participant dataSharing planned: No
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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.
Camille E Powe, MD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal A and Meal B in people with Gestational Diabetes, run by Massachusetts General Hospital at 2 sites 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak blood glucose following test meal (CGM) (time frame: 15 mins - 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04187521, which also lists 2 linked publications.
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 15 May 2026.