NCT04187521 (HINT-GDM) is a NA clinical trial of Meal A in Gestational Diabetes, sponsored by Massachusetts General Hospital.

Who is sponsoring NCT04187521?

NCT04187521 is sponsored by Massachusetts General Hospital.

What drugs are being tested in NCT04187521?

Interventions in NCT04187521: Meal A, Meal B.

What condition does NCT04187521 study?

NCT04187521 studies Gestational Diabetes.

Is NCT04187521 still recruiting?

NCT04187521 is currently status unknown. Last updated 10 May 2022.

Last reviewed 2022-05-10 · How we verify

NCT04187521: HINT-GDM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Heterogeneity Informed Nutrition Therapy for Gestational Diabetes Mellitus

Status unknown NA Last updated 10 May 2022

What this trial tests

NA trial testing Meal A in Gestational Diabetes in 60 participants. Status unknown.

Timeline

10 February 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	10 February 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	2 locations across United States

Drugs / interventions tested

Meal A
Meal B

Conditions studied

Gestational Diabetes — all drugs for Gestational Diabetes →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Defining Heterogeneity Among Women With Gestational Diabetes Mellitus.
Powe CE, Hivert MF, Udler MS. · · 2020 · cited 54× · PMID 32843565 · DOI 10.2337/dbi20-0004
Precision gestational diabetes treatment: a systematic review and meta-analyses.
Benham JL, Gingras V, McLennan NM, Most J, et al · · 2023 · cited 25× · PMID 37794196 · DOI 10.1038/s43856-023-00371-0
Physiological subtypes of gestational glucose intolerance and risk of adverse pregnancy outcomes.
Selen DJ, Edelson PK, James K, Corelli K, et al · · 2022 · cited 24× · PMID 34419453 · DOI 10.1016/j.ajog.2021.08.016

Verify or expand the search:

Other trials of Meal A

Trials testing the same drug.

NCT06822062 — Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption · NA · recruiting
NCT04489810 — Digestion of Gluten in the Presence of Enzymes · NA · completed
NCT04489836 — GlutDigest - Pilot Study · NA · completed

Other recruiting trials for Gestational Diabetes

Currently open trials in the same condition.

NCT07171684 — Single vs Multi-Dose Insulin for Glycemic Control (SUGAR) · NA · recruiting
NCT07314944 — Maternal Sleep and Lifestyle, Metabolic Health, and Perinatal Outcomes in Gestational Diabetes · recruiting
NCT06571487 — Growth Hormone Resistance of Beta-cells · recruiting
NCT07336914 — Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes · NA · recruiting
NCT07174245 — Pregnancy and Postpartum CGM in GDM · recruiting

Other Massachusetts General Hospital trials

Trials by the same sponsor.

NCT03585946 — Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis · withdrawn
NCT07214831 — A Feasibility and Acceptability Study of a Large Language Model-based Chatbot for Brief Alcohol Intervention Among Emerg · NA · not yet recruiting
NCT06686901 — A Randomized Controlled Trial of a Smartphone Delivered Treatment for Suicidal Thoughts and Behavior · NA · not yet recruiting
NCT05854212 — Behavioral Economics to Implement Nutrition Ranking in Food Pantries · NA · not yet recruiting
NCT07323446 — The MIND Study: The MGH/MIT Investigation of NAC on Dysregulation · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04187521 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 10 May 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04187521.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing