Effect of Low Glycemic Index on Gestational Diabetes Mellitus (MyLGI)
23 de enero de 2019 actualizado por: Barakatun Nisak Bt Mohd Yusof, Universiti Putra Malaysia
Investigating the Effectiveness of a Low Glycemic Index on Glycemic Control and Pregnancy Outcomes in Women With Gestational Diabetes Mellitus: A Randomised Controlled Trial
The purpose of this study is to determine whether glycemic index is effective in the treatment of maternal glycemia and pregnancy outcomes in women with Gestational Diabetes Mellitus.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
1. This research is divided into 2, that are study I and study II
Study I, is to determine the long-term effects of intervention (low GI and SNT) on maternal glycemia, pregnancy outcomes and postprandial metabolic markers in women with GDM
- A total of 110 women with confirmed diagnosis of GDM will be recruited
- They will be randomized either to receive low GI (n=55) or Standard Nutrition Therapy (SNT; n=55)
- The intervention will be started as soon as the women being diagnosed with GDM and they will be followed-up every month until delivery and up to the 3-month postpartum.
- The primary outcome measures include glycemic control parameters as assessed by fasting and postprandial glycemia, fructosamine, HbA1c, insulin level and requirement for insulin treatment.
- Secondary outcomes include lipid profile, weight gain, measures of postprandial metabolic response (free fatty acid and triglyceride), pregnancy outcomes, and overall improvement in postpartum metabolic parameters.
Study II, a sub-Mixed-meal Tolerant Test (MTT) study will be conducted to determine postprandial glycemic and metabolic responses before and after 4-weeks of intensive intervention
- During the 4-weeks of intensive intervention, the subjects will receive individualise counseling and daily food supply regarding the allocated study group.
- A minimum of 19 subjects from a pool of 110 subjects who is participated in the intervention study will be recruited.
- The MTT procedure is similar to the oral glucose tolerant test (OGTT) but the subject will be asked to consume the real mixed meals representing low and high GI foods rather than oral glucose solution.
- Subject will be asked to consume the test meal (either low or high GI foods) and the blood will be sampled before and after consuming the test meal in two different occasions with 1-week wash-out period.
- After one month of intensive intervention, 19 subjects from each arm will undergo the final HGI meal tolerant test (MTT3) and the same procedure of MTT 1 and 2
- Approximately 32μl of capillary blood by finger-prick will be obtained 7 times per MTT session, which is every 30 minutes thereafter to complete 3-h postprandial meal for each set of meal tests.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malasia, 56000
- Universiti Kebangsaan Malaysia Medical Centre
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Descripción
Study I
Inclusion Criteria:
- Pregnant women, aged 18-45 years
- Women diagnosed with Gestational Diabetes Mellitus (GDM) as early as 13 up to 28 weeks of gestation
- Pre-pregnancy BMI >23kg/m2 (using BMI cut-off point) for underweight and overweight of Asian as defined by World Health Organization (WHO, 2000)
- Treated with diet controlled or on insulin therapy
- Willing and able to comply with the study protocol
Exclusion Criteria:
- Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosemia, hyperemesis
- Any medical problem that requires steroid (i.e., arthritis, asthma, autoimmune diseases and skin conditions such as eczema
- Incapability to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Study II
Inclusion Criteria:
- Pregnant women, aged 18-45 years
- Only women diagnosed with Gestational Diabetes Mellitus (GDM) between 16 and 28 weeks of gestation
- Pre-pregnancy BMI >23kg/m2 (using BMI cut-off point) for underweight and overweight of Asian as defined by WHO (2000)
- Treated with diet-controlled alone
- Hemoglobin ≥10mmol/l (WHO, 2011)
- Willing and able to comply with the protocol
Exclusion Criteria:
- Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e., diabetes-related constipation or diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy, galactosemia, hyperemesis)
- Currently on insulin therapy
- With known food allergy/ on a particular dietary requirement
- Incapability to comply with study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Standard Nutrition Therapy
Subjects in this group receive a standard nutrition therapy based on local guidelines that is usually high in fibre with moderate to high glycemic index food
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Subjects will be advised on standard diet appropriate for the management of Gestational Diabetes Mellitus (GDM) designed to be high in fiber and have moderate to high dietary glycemic index
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|
Experimental: Low Glycemic Index
Subjects in this group receive intervention on low glycemic index foods
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Subjects will be advised to eat low glycemic index foods
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Post meal blood glucose level
Periodo de tiempo: 12 weeks
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Average blood glucose profiles after breakfast, lunch and dinner measured using capillary blood glucose at home
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12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Level of Triglycerides
Periodo de tiempo: 12 weeks
|
Changes in Fasting Triglycerides
|
12 weeks
|
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Level of glycemic control
Periodo de tiempo: 4 weeks
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Changes in Fructosamine
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4 weeks
|
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Maternal weight gain
Periodo de tiempo: 12 weeks
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Changes in total weight gain based on Institute of Medicine (IOM) recommendations
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12 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Level of post-meal blood glucose
Periodo de tiempo: 3 hour post-prandial
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Changes in post-meal blood glucose level
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3 hour post-prandial
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Barakatun-Nisak Mohd Yusof, PhD, Universiti Putra Malaysia
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Louie JC, Markovic TP, Ross GP, Foote D, Brand-Miller JC. Timing of peak blood glucose after breakfast meals of different glycemic index in women with gestational diabetes. Nutrients. 2012 Dec 21;5(1):1-9. doi: 10.3390/nu5010001.
- Moses RG, Barker M, Winter M, Petocz P, Brand-Miller JC. Can a low-glycemic index diet reduce the need for insulin in gestational diabetes mellitus? A randomized trial. Diabetes Care. 2009 Jun;32(6):996-1000. doi: 10.2337/dc09-0007. Epub 2009 Mar 11.
- Grant SM, Wolever TM, O'Connor DL, Nisenbaum R, Josse RG. Effect of a low glycaemic index diet on blood glucose in women with gestational hyperglycaemia. Diabetes Res Clin Pract. 2011 Jan;91(1):15-22. doi: 10.1016/j.diabres.2010.09.002. Epub 2010 Nov 20.
- Moses RG, Luebcke M, Davis WS, Coleman KJ, Tapsell LC, Petocz P, Brand-Miller JC. Effect of a low-glycemic-index diet during pregnancy on obstetric outcomes. Am J Clin Nutr. 2006 Oct;84(4):807-12. doi: 10.1093/ajcn/84.4.807.
- Perichart-Perera O, Balas-Nakash M, Rodriguez-Cano A, Legorreta-Legorreta J, Parra-Covarrubias A, Vadillo-Ortega F. Low Glycemic Index Carbohydrates versus All Types of Carbohydrates for Treating Diabetes in Pregnancy: A Randomized Clinical Trial to Evaluate the Effect of Glycemic Control. Int J Endocrinol. 2012;2012:296017. doi: 10.1155/2012/296017. Epub 2012 Nov 29.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de abril de 2014
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
4 de noviembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
9 de enero de 2019
Publicado por primera vez (Actual)
14 de enero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de enero de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
23 de enero de 2019
Última verificación
1 de enero de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5450647
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