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No dietary strategies have been designed and proved for Mexican pregnant women with diabetes. This is a randomized clinical trial of pregnant women with pregestational type 2 diabetes and gestational diabetes that were followed every two weeks until labor to assess the impact of the MNT program on metabolic control, maternal and fetal nutritional status and cost effectiveness. Participants were randomly assigned to one of three medical nutrition therapy (MNT) groups: the MNT 1 group (n=38) received usual medical treatment, counseling from a nutritionist and diabetes educator, using carbohydrate counting (40-45% of carbohydrates)with an intensive educational component; MNT2 group (n=50) had the same treatment, but included only low-moderate glycemic index foods; and NO-MNT group (n=45) received the current hospital treatment. All women will receive a glucose meter so they do self glucose monitoring (pre and postprandial) 2 times a weeks 6 times a day. Weight gain, dietary consumption and glucose concentrations will be evaluated every two weeks. Fetal outcomes (weight, length and presence of complications)will be measured at labor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. They received a specific diet using carbohydrate counting (40-45% of carbohydrates)and a moderate energy restriction. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring. |
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| 2 | Experimental | Women in this group received usual medical treatment and counseling from a nutritionist and diabetes educator. The diet they received was based on carbohydrate counting (40-45% of carbohydrates), but recommended only low-moderate glycemic index foods. Weight gain, adequacy of diet, results of the self glucose monitoring, and ketonuria were evaluated every two weeks. They also received education on diabetes, diet and glucose monitoring. |
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| 3 | No Intervention | women in this group received the current hospital treatment. They did not receive any intervention except for the self glucose monitoring that they did every two weeks. Weight gain and the results of the self glucose monitoring, were evaluated every two weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical nutrition therapy program | Other | the dietary guidelines were based on the Nutrition Practice guidelines for gestational diabetes developed by the American Dietetic Association. Dietary strategies were based on carbohydrate counting and/or restriction of high glycemic index foods. Even carbohydrate distribution throughout the day was emphasized. |
| Measure | Description | Time Frame |
|---|---|---|
| metabolic control | every two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| maternal nutritional status | every two weeks | |
| fetal nutritional status | at labor | |
| cost effectiveness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Vadillo-Ortega, M.D, PhD | Instituto Nacional de Perinatología Isidro Espionosa de los Reyes | Study Chair |
| Otilia Perichart-Perera, M.S, RD | Instituto Nacional de Perinatología Isidro Espionosa de los Reyes | Principal Investigator |
| Margie Balas-Nakash, B.S | Instituto Nacional de Perinatología Isidro Espionosa de los Reyes | Study Chair |
| Adalberto Parra-Covarrubias, M.D | Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Study Chair |
| Ameyalli Rodriguez-Cano, B.S | Instituto Nacional de Perinatología Isidro Espinosa de los Reyes | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes | Mexico City | Mexico City | 11700 | Mexico |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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|
| 3 years |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |