Clinical trial · Interventional
Medical Nutrition Therapy Plus Transgestational Metformin For Preventing Gestational Diabetes In High Risk Mexican Women
EFFECTIVITY OF MEDICAL NUTRITION THERAPY PLUS TRANSGESTATIONAL METFORMIN FOR PREVENTING THE INCIDENCE OF GESTATIONAL DIABETES MELLITUS IN HIGH RISK MEXICAN WOMEN.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| History of Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Pregestational Obesity (BMI > 27kg/m2) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical nutrition therapy | Behavioral | — | UNRESOLVED |
| medical nutrition therapy + metformin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- medical nutrition therapy + metformin
- description
- medical nutrition therapy plus trans-gestational metformin (850mg 2 times day)
- interventionNames
- Drug: medical nutrition therapy + metformin
- type
- ACTIVE_COMPARATOR
- label
- medical nutrition therapy
- description
- medical nutrition therapy without trans-gestational metformin
- interventionNames
- Behavioral: Medical nutrition therapy
Primary outcomes (1)
- measure
- Gestational diabetes mellitus
- timeFrame
- 27-28 weeks of gestation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Mexican women with pregnancy \< 16 weeks of gestation, normal oral glucose tolerance 75g-2h test and 3 or more criteria: 1. Body mass index \> 27 kg/m2 2. Maternal age \>25 3. History of infertility with polycystic ovary syndrome 4. History of macrosomic newborn (Weight \>4000g) 5. History of diabetes mellitus in first or second degree. 6. History of gestational diabetes in previous pregnancy Exclusion Criteria: * Any form of pregestational diabetes * Fasting glucose \> 126 mg/dL at first prenatal visit. * seric creatinine \> 1.5 mg/dL * Hyperthyroidism * Heart disease * Hepatic disease * Renal diseases * Epilepsy * Lupus * Chronic hypertension.
References
Publications (1)
- DERIVEDPerichart-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. PMID 35010938