Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial

NCT06355154 | Recruiting

• 1 other identifier: 069823- HMO-CTIL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Diabetes in Pregnancy

Keywords

Diabetes in pregnancy; Glycemic balance; Low Carbohydrates; Time in range; Ketosis

Outcome Measures

Primary Outcomes (2)

• Time in range

  Percentage of time during the day that the patient is in the normal range of glucose balance in pregnancy

  24 hours

• Time above range

  Percentage of time during the day that the patient is above the normal range of glucose balance in pregnancy

  24 hours

Study Arms (2)

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)

Other: Nutritional intervention

Interventions

Nutritional intervention OTHER

The intervention will contain a diet with a reduced amount of carbohydrates compared to the standard treatment today but without caloric restriction.

The moderate carbohydrate diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Individual with risk factors for:
• Placental insufficiency.
• Hypertension.
• Renal disease.
• Thrombophilia
• Rheumatologic disease.
• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Hospital

Jerusalem, Israel

RECRUITING

Related Publications (12)

• 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.

  PMID: 32404325 BACKGROUND

• Petry 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.

  PMID: 20487576 BACKGROUND

• McIntyre 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.

  PMID: 31296866 BACKGROUND

• Sweeting 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.

  PMID: 35041752 BACKGROUND

• ElSayed 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.

  PMID: 36507645 BACKGROUND

• lD Meyers, JP Hellwig JO. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. 2006.

  BACKGROUND

• 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.

  PMID: 34444759 BACKGROUND

• Tanner 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.

  PMID: 37971504 BACKGROUND

• Mijatovic 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.

  PMID: 32537643 BACKGROUND

• Shalit1 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

• 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.

  PMID: 1748252 BACKGROUND

• Major 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.

  PMID: 9540949 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Ketosis

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Acidosis; Acid-Base Imbalance

Central Study Contacts

Genya Aharon Hananel, DR MD PHD

CONTACT

0525576455; Genyah@hadassah.org.il

naama shirazi, mrs

CONTACT

0524664668; naamon20@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 9, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)