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| ID | Type | Description | Link |
|---|---|---|---|
| INPer (Mexico) | Registry Identifier | 21225042101 |
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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
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Gestational diabetes mellitus is one of the most frequent complications of pregnancy, that affect between 1 to 14% of population around the world.
There is a few studies to prevent gestational diabetes mellitus in high risk women as Mexican population.
Metformin has been used during pregnancy in women with gestational diabetes and women with polycystic ovary syndrome, with acceptable security for mother and fetus.
Metformin decrease the insulin resistance and weight gain, we believe that metformin may be decrease the risk of gestational diabetes mellitus in high risk women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medical nutrition therapy + metformin | Experimental | medical nutrition therapy plus trans-gestational metformin (850mg 2 times day) |
|
| medical nutrition therapy | Active Comparator | medical nutrition therapy without trans-gestational metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| medical nutrition therapy + metformin | Drug |
| ||
| Medical nutrition therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational diabetes mellitus | oral glucose tolerance test | 27-28 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| insulin resistance | measure of insulin resistance by HOMA-IR, sample of umbilical cord | At birth |
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Inclusion Criteria:
Mexican women with pregnancy < 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrique Reyes-Muñoz, PhD | National Institute of Perinatology, Mexico City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Perinatology | México | State of Mexico | 11000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35010938 | Derived | Perichart-Perera O, Mier-Cabrera J, Flores-Robles CM, Martinez-Cruz N, Arce-Sanchez L, Alvarado-Maldonado IN, Montoya-Estrada A, Romo-Yanez J, Rodriguez-Cano AM, Estrada-Gutierrez G, Espino Y Sosa S, Guzman-Huerta M, Ayala-Yanez R, Reyes-Munoz E. Intensive Medical Nutrition Therapy Alone or with Added Metformin to Prevent Gestational Diabetes Mellitus among High-Risk Mexican Women: A Randomized Clinical Trial. Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062. |
| Label | URL |
|---|---|
| Medical Nutrition Therapy Plus Metformin for Preventing Gestational Diabetes Among High-Risk Women. | View source |
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| Behavioral |
medical nutrition therapy |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D011085 | Polycystic Ovary Syndrome |
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D011248 | Pregnancy Complications |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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