Diabetes in PregnancyNCT06355154
Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial
A study testing Nutritional intervention in people with Diabetes in Pregnancy, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diabetes in Pregnancy
- What is being tested?
- Nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 28 May 2024to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- • Pregnant women with singleton pregnancies.
- Over 18 years old.
- Diagnosis of GDM- 3-h 100-g OGTT according to the American College of Obstetricians and Gynecologists supported by the American Diabetes Association, Or Diagnosis of type 1 or 2 diabetes before pregnancy, Or Diagnosis of early GDM by either OGTT in the first trimester or elevated blood glucose measurements in the fasting (above 95mg/dl) or the postprandial (above 140 mg/dl) state.
- Are already on or intended to start intensive insulin treatment (at leased 2 injections of insulin per day) or wear an insulin pump.
- Are willing to wear a continuous glucose monitoring system.
- BMI of 18.5-42 kg/m2 at the time of diagnosis.
Who cannot join
- Individual with risk factors for:
- Placental insufficiency.
- Hypertension.
- Renal disease.
- Thrombophilia
- Rheumatologic disease.
Show all 9Show fewer
- A history of preeclampsia, or fetal growth restriction (IUGR).
- Individuals with a history of preterm labor, or concomitant therapy with β-blockers or glucocorticoids.
- Individuals who smoke and/or consume any amount of alcohol during pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Hospital
Jerusalem
Genya hananel aharOn, MD PHD, +972- 52-557-6455, Genyah@hadassah.org.il
Naama Shirazi, RD MSC, +972-52-466-4668, naamon20@gmail.com
About this study
Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT.
Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT.
Read the detailed description
Effects of moderate carbohydrate consumption on metabolic and obstetric outcomes in pregnant women with insulin-treated diabetes- A randomized controlled trial
- Scientific Background: 1.1 Diabetes Mellitus in Pregnancy: Diabetes during pregnancy (pre-gestational type 1 or 2, or gestational diabetes) is associated with complications for both the mother (polyhydramnios, miscarriage, hypertension, preeclampsia, need for instrumental delivery) and the fetus/neonate (birth defects, macrosomia, shoulder dystocia, respiratory distress, hyperbilirubinemia, hypoglycemia). (1),(2) ,(3),(4). The incidence of all forms of diabetes during reproductive age is increasing(5). 1.2 Dietary carbohydrate consumption during pregnancy: Current guidelines recommend a minimum carbohydrate consumption of 175g/day for all pregnant women, regardless of diabetes status. This is based on a theoretical calculations rather than clinical evidence (6). Some concerns with carbohydrate restriction during pregnancy include disrupting the maternal-fetal glucose gradient, increased fetal ketone exposure, micronutrient deficiency, and increased maternal triglycerides/free fatty acids(7). However, recent studies found no correlation between moderate carbohydrate restriction (<175g/day but >120g/day) and increased ketosis(8),(9),(10). Reducing carbohydrates may help reduce postprandial hyperglycemia in patients on intensive insulin therapy(11),(12).These findings call into question the hypothetical assumption that a minimum of 175 gr of CHO is required during pregnancy.
- Research Objective: The primary objectives of the trial are to determine:
- To assess the effectiveness and safety of moderate carbohydrate consumption restriction (MCD) in enhancing glycemic control.
- To investigate the impact of MCD on the metabolomic profile of pregnant individuals with diabetes requiring intensive insulin treatment (MDI/CII).
- Expected Significance:
The importance of this study lies in:
- Challenging the commonly accepted but theoretical recommendation of 175g/day minimum carbohydrate intake during pregnancy.
- Evaluating if moderate carbohydrate restriction can improve glycemic control and pregnancy outcomes in women with diabetes requiring intensive insulin therapy, without major adverse effects.
4.Detailed Description of the Proposed Research: 4.1 Study Design: This is an open label, randomized controlled trial comprising 120 pregnant individuals (18-45 years) with any form of diabetes requiring intensive insulin therapy. Pregnant individuals on IIT will be randomized to standard carbohydrate diet (>175g/day) or moderate carbohydrate diet (120g/day) group.
Key Measurements/Data Collection:
- Continuous glucose monitoring (CGM) to assess time in range (TIR) and other glycemic parameters.
- Anthropometrics (weight, height, BMI).
- Dietary intake data (FFQs, 24-hr recalls, 3-day food diaries).
- Blood tests (HbA1c, glucose, c-peptide, lipids, etc).
- Fetal growth monitoring via ultrasound.
- Cord blood c-peptide at delivery.
- Neonatal and maternal post-delivery outcomes (mode of delivery, weight, complications, etc).
- Maternal metabolomics (fasting blood sample). 4.3 Study Visits:
- Screening/baseline visit to assess eligibility.
- Dietary counseling and medical team visits every 2 weeks until 32 weeks, then weekly or as be decided by the medical team according to patients needs.
- Fetal ultrasounds start at 28 weeks, twice monthly or more.
- Final visit at 35-38 weeks for metabolomics sample. 4.4 Safety Monitoring:
- No intended calorie restriction.
- CGM to adjust insulin and avoid hypoglycemia.
- Home ketone monitoring.
- Ultrasound fetal growth monitoring. 4.5 Metabolomics Analysis:
- LC-MS analysis to detect >400 metabolites.
- Assess effects on micronutrients, carbs, lipids, ketones, amino acids.
- Identify metabolic pathways affected and correlate with pregnancy outcomes. 4.6 Research Calculation: 120 participants total (60 per group). 80% power to detect 7% difference in time in range (TIR) between group. Assumptions based on literature, including CONCEPTT study standard deviation 4.7 Ethical Approval: Study will follow Declaration of Helsinki. Institutional ethics approval obtained 5. Research Environment: The study will be conducted at 3-4 major medical centers in Israel with expertise in high-risk pregnancies. Qualified clinical staff including doctors, nurses, dietitians and researchers will be involved in participant recruitment, intervention delivery, data collection and analysis. Necessary equipment like CGMs, metabolomics instruments, etc. are available at these sites.
- Conditions
- Diabetes in Pregnancy
- Being tested
- Nutritional intervention
- Keywords
- Diabetes in pregnancy, Glycemic balance, Low Carbohydrates, Time in range, Ketosis
- Medical subject headings
- Diabetes, Gestational, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionOther
The intervention will contain a diet with a reduced amount of carbohydrates compared to the standard treatment today but without caloric restriction.
| Study group | Role | What they receive |
|---|---|---|
| The Standard of Care diet | No intervention | (a diet that includes at least 175 grams of carbohydrates per day or more/ >40% CHO, SCD) |
| The moderate carbohydrate diet | Experimental | (a diet with 120 grams of carbohydrates and customized according to pregnancy requirements/ <40% CHO, MCD) Receives: Other: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
Percentage of time during the day that the patient is in the normal range of glucose balance in pregnancy
Measured: 24 hours
Time above range
Percentage of time during the day that the patient is above the normal range of glucose balance in pregnancy
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 posted9 Apr 2024
- Study start28 May 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetes 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06355154
- Sponsor's protocol ID
- 069823- HMO-CTIL
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vounzoulaki E, Khunti K, Abner SC, Tan BK, Davies MJ, Gillies CL. Progression to type 2 diabetes in women with a known history of gestational diabetes: systematic review and meta-analysis. BMJ. 2020 May 13;369:m1361. doi: 10.1136/bmj.m1361.
PubMed 32404325Petry CJ. Gestational diabetes: risk factors and recent advances in its genetics and treatment. Br J Nutr. 2010 Sep;104(6):775-87. doi: 10.1017/S0007114510001741. Epub 2010 May 21.
PubMed 20487576McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.
PubMed 31296866Sweeting A, Wong J, Murphy HR, Ross GP. A Clinical Update on Gestational Diabetes Mellitus. Endocr Rev. 2022 Sep 26;43(5):763-793. doi: 10.1210/endrev/bnac003.
PubMed 35041752ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Jeffrie Seley J, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S254-S266. doi: 10.2337/dc23-S015.
PubMed 36507645lD Meyers, JP Hellwig JO. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. 2006.
Sweeting A, Mijatovic J, Brinkworth GD, Markovic TP, Ross GP, Brand-Miller J, Hernandez TL. The Carbohydrate Threshold in Pregnancy and Gestational Diabetes: How Low Can We Go? Nutrients. 2021 Jul 28;13(8):2599. doi: 10.3390/nu13082599.
PubMed 34444759Tanner HL, Ng HT, Murphy G, Barrett HL, Callaway LK, McIntyre HD, Nitert MD. Habitual carbohydrate intake is not correlated with circulating beta-hydroxybutyrate levels in pregnant women with overweight and obesity at 28 weeks' gestation. Diabetologia. 2024 Feb;67(2):346-355. doi: 10.1007/s00125-023-06044-w. Epub 2023 Nov 16.
PubMed 37971504Mijatovic J, Louie JCY, Buso MEC, Atkinson FS, Ross GP, Markovic TP, Brand-Miller JC. Effects of a modestly lower carbohydrate diet in gestational diabetes: a randomized controlled trial. Am J Clin Nutr. 2020 Aug 1;112(2):284-292. doi: 10.1093/ajcn/nqaa137.
PubMed 32537643Shalit1 R, Dayan2 N, Yoeli-Ullman2 R, , T. Cukierman-Yaffe1 3; The relationship between low carbohydrate diet and pregnancy outcomes in women with pre_gestational diabetes: a historical prospective study. EASD [Internet]. Barcelona; 2019. Available from: https://www.easd.org/media-centre/home.html#!resources/the-relationship-between-low-carbohydrate-diet-and-pregnancy-outcomes-in-women-with-pre-gestational-diabetes-a-historical-prospective-study
Peterson CM, Jovanovic-Peterson L. Percentage of carbohydrate and glycemic response to breakfast, lunch, and dinner in women with gestational diabetes. Diabetes. 1991 Dec;40 Suppl 2:172-4. doi: 10.2337/diab.40.2.s172.
PubMed 1748252Major CA, Henry MJ, De Veciana M, Morgan MA. The effects of carbohydrate restriction in patients with diet-controlled gestational diabetes. Obstet Gynecol. 1998 Apr;91(4):600-4. doi: 10.1016/s0029-7844(98)00003-9.
PubMed 9540949
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06355154
- Acronym / sponsor ID
- 069823- HMO-CTIL
- Conditions
- Diabetes in Pregnancy
- Keywords
- Diabetes in pregnancy, Glycemic balance, Low Carbohydrates, Time in range, Ketosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 9 Apr 2024 (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.
Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT.
Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT.
Detailed description
Effects of moderate carbohydrate consumption on metabolic and obstetric outcomes in pregnant women with insulin-treated diabetes- A randomized controlled trial
- Scientific Background: 1.1 Diabetes Mellitus in Pregnancy: Diabetes during pregnancy (pre-gestational type 1 or 2, or gestational diabetes) is associated with complications for both the mother (polyhydramnios, miscarriage, hypertension, preeclampsia, need for instrumental delivery) and the fetus/neonate (birth defects, macrosomia, shoulder dystocia, respiratory distress, hyperbilirubinemia, hypoglycemia). (1),(2) ,(3),(4). The incidence of all forms of diabetes during reproductive age is increasing(5). 1.2 Dietary carbohydrate consumption during pregnancy: Current guidelines recommend a minimum carbohydrate consumption of 175g/day for all pregnant women, regardless of diabetes status. This is based on a theoretical calculations rather than clinical evidence (6). Some concerns with carbohydrate restriction during pregnancy include disrupting the maternal-fetal glucose gradient, increased fetal ketone exposure, micronutrient deficiency, and increased maternal triglycerides/free fatty acids(7). However, recent studies found no correlation between moderate carbohydrate restriction (<175g/day but >120g/day) and increased ketosis(8),(9),(10). Reducing carbohydrates may help reduce postprandial hyperglycemia in patients on intensive insulin therapy(11),(12).These findings call into question the hypothetical assumption that a minimum of 175 gr of CHO is required during pregnancy.
- Research Objective: The primary objectives of the trial are to determine:
- To assess the effectiveness and safety of moderate carbohydrate consumption restriction (MCD) in enhancing glycemic control.
- To investigate the impact of MCD on the metabolomic profile of pregnant individuals with diabetes requiring intensive insulin treatment (MDI/CII).
- Expected Significance:
The importance of this study lies in:
- Challenging the commonly accepted but theoretical recommendation of 175g/day minimum carbohydrate intake during pregnancy.
- Evaluating if moderate carbohydrate restriction can improve glycemic control and pregnancy outcomes in women with diabetes requiring intensive insulin therapy, without major adverse effects.
4.Detailed Description of the Proposed Research: 4.1 Study Design: This is an open label, randomized controlled trial comprising 120 pregnant individuals (18-45 years) with any form of diabetes requiring intensive insulin therapy. Pregnant individuals on IIT will be randomized to standard carbohydrate diet (>175g/day) or moderate carbohydrate diet (120g/day) group.
Key Measurements/Data Collection:
- Continuous glucose monitoring (CGM) to assess time in range (TIR) and other glycemic parameters.
- Anthropometrics (weight, height, BMI).
- Dietary intake data (FFQs, 24-hr recalls, 3-day food diaries).
- Blood tests (HbA1c, glucose, c-peptide, lipids, etc).
- Fetal growth monitoring via ultrasound.
- Cord blood c-peptide at delivery.
- Neonatal and maternal post-delivery outcomes (mode of delivery, weight, complications, etc).
- Maternal metabolomics (fasting blood sample). 4.3 Study Visits:
- Screening/baseline visit to assess eligibility.
- Dietary counseling and medical team visits every 2 weeks until 32 weeks, then weekly or as be decided by the medical team according to patients needs.
- Fetal ultrasounds start at 28 weeks, twice monthly or more.
- Final visit at 35-38 weeks for metabolomics sample. 4.4 Safety Monitoring:
- No intended calorie restriction.
- CGM to adjust insulin and avoid hypoglycemia.
- Home ketone monitoring.
- Ultrasound fetal growth monitoring. 4.5 Metabolomics Analysis:
- LC-MS analysis to detect >400 metabolites.
- Assess effects on micronutrients, carbs, lipids, ketones, amino acids.
- Identify metabolic pathways affected and correlate with pregnancy outcomes. 4.6 Research Calculation: 120 participants total (60 per group). 80% power to detect 7% difference in time in range (TIR) between group. Assumptions based on literature, including CONCEPTT study standard deviation 4.7 Ethical Approval: Study will follow Declaration of Helsinki. Institutional ethics approval obtained 5. Research Environment: The study will be conducted at 3-4 major medical centers in Israel with expertise in high-risk pregnancies. Qualified clinical staff including doctors, nurses, dietitians and researchers will be involved in participant recruitment, intervention delivery, data collection and analysis. Necessary equipment like CGMs, metabolomics instruments, etc. are available at these sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| The Standard of Care diet | No intervention | –(a diet that includes at least 175 grams of carbohydrates per day or more/ >40% CHO, SCD) |
| The moderate carbohydrate diet | Experimental | Other: Nutritional intervention(a diet with 120 grams of carbohydrates and customized according to pregnancy requirements/ <40% CHO, MCD) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Pregnant women with singleton pregnancies.
Key exclusion criteria (9 listed)
- Individual with risk factors for:
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 interventionThe intervention will contain a diet with a reduced amount of carbohydrates compared to the standard treatment today but without caloric restriction. | Other | The moderate carbohydrate diet |
Primary outcome
Time in range
Time frame: 24 hours
Percentage of time during the day that the patient is in the normal range of glucose balance in pregnancy
Time above range
Time frame: 24 hours
Percentage of time during the day that the patient is above the normal range of glucose balance in pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 32404325Vounzoulaki E, Khunti K, Abner SC, Tan BK, Davies MJ, Gillies CL. Progression to type 2 diabetes in women with a known history of gestational diabetes: systematic review and meta-analysis. BMJ. 2020 May 13;369:m1361. doi: 10.1136/bmj.m1361.
- Background: PubMed 20487576Petry CJ. Gestational diabetes: risk factors and recent advances in its genetics and treatment. Br J Nutr. 2010 Sep;104(6):775-87. doi: 10.1017/S0007114510001741. Epub 2010 May 21.
- Background: PubMed 31296866McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8.
- Background: PubMed 35041752Sweeting A, Wong J, Murphy HR, Ross GP. A Clinical Update on Gestational Diabetes Mellitus. Endocr Rev. 2022 Sep 26;43(5):763-793. doi: 10.1210/endrev/bnac003.
- Background: PubMed 36507645ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Jeffrie Seley J, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S254-S266. doi: 10.2337/dc23-S015.
- BackgroundlD Meyers, JP Hellwig JO. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. 2006.
- Background: PubMed 34444759Sweeting A, Mijatovic J, Brinkworth GD, Markovic TP, Ross GP, Brand-Miller J, Hernandez TL. The Carbohydrate Threshold in Pregnancy and Gestational Diabetes: How Low Can We Go? Nutrients. 2021 Jul 28;13(8):2599. doi: 10.3390/nu13082599.
- Background: PubMed 37971504Tanner HL, Ng HT, Murphy G, Barrett HL, Callaway LK, McIntyre HD, Nitert MD. Habitual carbohydrate intake is not correlated with circulating beta-hydroxybutyrate levels in pregnant women with overweight and obesity at 28 weeks' gestation. Diabetologia. 2024 Feb;67(2):346-355. doi: 10.1007/s00125-023-06044-w. Epub 2023 Nov 16.
- Background: PubMed 32537643Mijatovic J, Louie JCY, Buso MEC, Atkinson FS, Ross GP, Markovic TP, Brand-Miller JC. Effects of a modestly lower carbohydrate diet in gestational diabetes: a randomized controlled trial. Am J Clin Nutr. 2020 Aug 1;112(2):284-292. doi: 10.1093/ajcn/nqaa137.
- BackgroundShalit1 R, Dayan2 N, Yoeli-Ullman2 R, , T. Cukierman-Yaffe1 3; The relationship between low carbohydrate diet and pregnancy outcomes in women with pre_gestational diabetes: a historical prospective study. EASD [Internet]. Barcelona; 2019. Available from: https://www.easd.org/media-centre/home.html#!resources/the-relationship-between-low-carbohydrate-diet-and-pregnancy-outcomes-in-women-with-pre-gestational-diabetes-a-historical-prospective-study
- Background: PubMed 1748252Peterson CM, Jovanovic-Peterson L. Percentage of carbohydrate and glycemic response to breakfast, lunch, and dinner in women with gestational diabetes. Diabetes. 1991 Dec;40 Suppl 2:172-4. doi: 10.2337/diab.40.2.s172.
- Background: PubMed 9540949Major CA, Henry MJ, De Veciana M, Morgan MA. The effects of carbohydrate restriction in patients with diet-controlled gestational diabetes. Obstet Gynecol. 1998 Apr;91(4):600-4. doi: 10.1016/s0029-7844(98)00003-9.
- 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.
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 intervention in people with Diabetes in Pregnancy, run by Hadassah Medical Organization at 1 site in Israel.
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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Oct 2025. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Genya Aharon Hananel, DR MD PHD (0525576455, Genyah@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT06355154, which also lists 12 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 2 Oct 2025.