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There is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. There is not major evidence that any given macronutrient percentage may be recommended to treat a woman with Gestational Diabetes Mellitus (GDM). In the investigators' country, insulin is the second-line treatment once medical nutrition therapy (MNT) has failed to control glucose levels during pregnancy. Insulin treatment is more expensive and not as well accepted as MNT. The investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low CHO | Experimental | Diet with 40% total calories from carbohydrates. |
|
| High CHO | Active Comparator | Diet with 55% total calories from carbohydrates. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low CHO | Behavioral | Diet with 40% total calories from carbohydrates. In the "Low-CHO" arm, 15% of calories from carbohydrates will be substituted by monounsaturated fat. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need of insulin treatment for GDM | Day of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Time from GDM diagnosis free of insulin treatment | Day of delivery | |
| Maternal ketonemia and/or ketonuria | Day of delivery | |
| Maternal morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didac Mauricio, MD PhD | Hospital Universitari Arnau de Vilanova | Study Director |
| Marta Hernández, MD | Hospital Universitari Arnau de Vilanova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Arnau de Vilanova | Lleida | Lleida | 25198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18058723 | Background | Cypryk K, Kaminska P, Kosinski M, Pertynska-Marczewska M, Lewinski A. A comparison of the effectiveness, tolerability and safety of high and low carbohydrate diets in women with gestational diabetes. Endokrynol Pol. 2007 Jul-Aug;58(4):314-9. | |
| 1748252 | 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. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| High CHO diet | Dietary Supplement | Diet with 55% total calories from carbohydrates. |
|
| Day of delivery |
| Fetal morbidity | 1 month after delivery |
| 9540949 | 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. |
| 23564917 | Derived | Moreno-Castilla C, Hernandez M, Bergua M, Alvarez MC, Arce MA, Rodriguez K, Martinez-Alonso M, Iglesias M, Mateu M, Santos MD, Pacheco LR, Blasco Y, Martin E, Balsells N, Aranda N, Mauricio D. Low-carbohydrate diet for the treatment of gestational diabetes mellitus: a randomized controlled trial. Diabetes Care. 2013 Aug;36(8):2233-8. doi: 10.2337/dc12-2714. Epub 2013 Apr 5. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |