Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
29 de julio de 2026 actualizado por: Riphah International University
- To compare the effects of metformin, insulin, and their combination with multistrain probiotics on glycemic control and insulin resistance in women with gestational diabetes mellitus (GDM), assessed by FPG, HbA1c, fasting insulin, and HOMA-IR.
- To compare the effects of metformin, insulin, and their combination with multistrain probiotics on inflammatory biomarkers in women with GDM.
- To determine the effect of multistrain probiotic supplementation alongside standard therapy on maternal and neonatal outcomes, including gestational age at delivery, mode of delivery, birth weight, Apgar score, and NICU admission.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
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.
Estudio Contacto
- Nombre: Jawaria Iftikhar, phd*
- Número de teléfono: 03004219529
- Correo electrónico: jawaria.iftikhar@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Rawalpindi, Punjab Province, Pakistán, 46000
- Reclutamiento
- Pakistan Railway Hospital
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Contacto:
- Jawaria Iftikhar, PHD*
- Número de teléfono: 923004219529
- Correo electrónico: jawaria.iftikhar@riphah.edu.pk
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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
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Pregnant women (18-45 years of age).
- Diagnosed with GDM between 18-26 weeks of gestation.
- Singleton pregnancy. (Multiple gestations carry inherently higher risks like preterm birth, growth restriction and neonatal morbidity, Inclusion may introduce confounding thus restricting singleton pregnancies ensures population homogeneity).
Exclusion Criteria:
- Pre-existing diabetes mellitus.
- Pregnancy induced hypertension.
- Chronic gastrointestinal, hepatic, or renal disease.
- Use of antibiotics or probiotics within the previous 4 weeks.
- Multiple pregnancy.
- Pregnancy with known fetal anomalies.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: GRP 1 Tab metformin
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Tab metformin 500 mg TDS for 12 weeks
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Comparador activo: GRP 2 Inj insulin
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Inj insulin s/c BD for 12 weeks
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Experimental: GRP 3 Tab metformin + HI flora sachet
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Tab metformin 500 mg TDS + HI flora sachet OD for 12 weeks
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Experimental: GRP 4 Inj insulin + HI flora
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Inj insulin s/c BD + HI flora sachet OD for 12 weeks
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fasting blood glucose levels
Periodo de tiempo: 12 week
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A fasting blood sugar level measures the amount of glucose in blood after patient has not eaten for at least 8 hours.
It is primarily used to screen for or monitor prediabetes and diabetes.
Fasting glucose is categorized as follows: Normal: Less than 100 mg/dL (5.6 mmol/L), Prediabetes: 100 to 125 mg/dL (5.6 to 6.9 mmol/L), Diabetes: 126 mg/dL (7.0 mmol/L) or higher on two separate tests.
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12 week
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Fasting Serum Insulin Levels
Periodo de tiempo: 12 week
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A serum fasting insulin test measures the amount of insulin in patient's blood after an overnight fast.
It is used to evaluate pancreatic function, investigate hypoglycemia, and identify early-stage insulin resistance.Standard Lab Range: 2 to 25uIU/mL.
Interpretation: High Levels (Hyperinsulinemia): Usually indicate insulin resistance, where cells do not respond properly to insulin, forcing the pancreas to produce excess amounts.
It can precede prediabetes and Type 2 diabetes by years, even when blood sugar remains normal.
Other causes include obesity, polycystic ovary syndrome (PCOS), and Cushing's syndrome.Low Levels: Suggest impaired or destroyed insulin-producing pancreatic beta cells.
Common causes include Type 1 diabetes, chronic pancreatitis, or advanced Type 2 diabetes where the pancreas is "burned out"
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12 week
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Homeostatic Model Assessment of Insulin Resistance
Periodo de tiempo: 12 week
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It is a widely used medical tool that estimates how effectively your body regulates blood sugar.
It acts as an indirect, highly accessible indicator of insulin resistance, helping assess the risk of type 2 diabetes and metabolic syndrome.
Interpretation: Optimal / Sensitive: Under 1.0.
Your body is highly sensitive to insulin and manages glucose well.Early Insulin Resistance: 1.0 to 2.9 (or greater than 1.9, depending on the diagnostic criteria).
Your body is starting to require more insulin to keep blood sugar stable.Significant Insulin Resistance: Above 2.9 (or as low as 2.5 for some populations, particularly in Asian demographics)
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12 week
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Glycated Hemoglobin
Periodo de tiempo: 12 week
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Glycated hemoglobin (HbA1c) is a blood test that measures your average blood sugar levels over the past 2 to 3 months.
It checks how much sugar has bonded to your hemoglobin, and is primarily used to diagnose prediabetes and diabetes, Below 5.7%: Normal / Healthy 5.7% to 6.4%: Prediabetes 6.5% or higher: Diabetes (diagnosed on two separate tests)
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12 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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High-sensitivity C-reactive protein
Periodo de tiempo: 12 week
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it is a specialized blood test that measures very low levels of C-Reactive Protein to detect chronic, low-grade inflammation in the body.
Results generally fall into one of three cardiovascular risk categories:Low Risk: Less than 1.0 mg/L Moderate Risk: 1.0 to 3.0 mg/L High Risk: Greater than 3.0 mg/
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12 week
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Neutrophil-to-Lymphocyte ratio
Periodo de tiempo: 12 week
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The neutrophil-to-lymphocyte ratio (NLR) is a simple, readily available biomarker calculated by dividing your absolute neutrophil count by your absolute lymphocyte count from a routine Complete Blood Count (CBC).
It serves as a strong indicator of systemic inflammation.Average Normal NLR: Between (0.78) and (3.53) (the population average typically sits around (1.65)).Elderly Adults (Over 75): Normal ranges can extend up to (8.80) due to natural immunosenescence (aging of the immune system).
Elevated NLR: Ratios above the normal range usually indicate physiological stress, systemic inflammation, infection, or tissue damage.
Markedly elevated scores (e.g.,(>9.0))
are often seen in severe acute conditions like sepsis
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12 week
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Adiponectin
Periodo de tiempo: 12 week
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Adiponectin is a protein hormone and adipokine produced primarily by fat cells (adipose tissue) that regulates glucose levels, fatty acid breakdown, and inflammation.
It plays a crucial role in enhancing insulin sensitivity and protecting the body against metabolic diseases like Type 2 diabetes and cardiovascular disease.
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12 week
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fetal Abdominal Circumference
Periodo de tiempo: 12 week
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Fetal Abdominal Circumference (AC) is a routine ultrasound measurement used to monitor fetal growth, estimate fetal weight, and check for growth abnormalities.
It is one of the most reliable indicators of a baby's weight and overall physical development during pregnancy.
Typical Normal Ranges for the AC during the second and third trimesters include:20 Weeks: ~14.5 cm to 16.5 cm 28 Weeks: ~22.5 cm to 25.5 cm 34 Weeks: ~28.0 cm to 31.0 cm 36 Weeks: ~31.0 cm to 34.0 cm
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12 week
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thickness of placenta
Periodo de tiempo: 12 week
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Placental thickness generally increases linearly by about 1 mm per week of pregnancy, roughly correlating in millimeters to your gestational age in weeks (e.g., 30 mm thick at 30 weeks).
A normal placenta typically reaches a maximum thickness of about 4 cm (40 mm) at full term.Abnormal placental thickness, measured via ultrasound can provide critical clues about maternal and fetal health.
Thick Placenta (>4 cm): A placenta that is too thick can sometimes indicate underlying issues such as maternal diabetes, infection, fetal anemia, or issues with blood flow.Thin Placenta (<2.5 cm): A placenta that is unusually thin, especially in the third trimester, may be a sign of placental insufficiency (where the placenta doesn't provide enough blood and nutrients to the baby) or intrauterine growth restriction (IUGR).
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12 week
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Amniotic Fluid Index
Periodo de tiempo: 12 week
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The Amniotic Fluid Index (AFI) is an ultrasound measurement used to estimate the amount of amniotic fluid surrounding a baby in the womb.
It serves as a vital indicator of fetal well-being and placental function.
Low AFI (<5 cm): May indicate dehydration, placental issues, or potential issues with fetal kidney development.
It often requires closer monitoring or additional testing.High AFI (>25 cm): May be linked to gestational diabetes, multiple gestations (e.g., twins), or fetal gastrointestinal/swallowing abnormalities.
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12 week
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Gestational age at delivery
Periodo de tiempo: 39 weeks
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For pregnancies complicated by gestational diabetes, the optimal gestational age for delivery is typically between 38 and 39 weeks for diet-controlled cases, and between 37 and 39 weeks for cases requiring medication or those with maternal complications.
Blood Glucose Control: Women who require insulin or oral medications to regulate glucose generally require earlier delivery (37-38 weeks) compared to those managing through diet alone.
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39 weeks
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Mode of delivery
Periodo de tiempo: 39 week
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Well-Controlled GDM: If blood sugar levels remain stable and there are no signs of fetal distress, you may be allowed to wait for natural labor to begin up to week 40.Poor Control or Complications: If blood sugar is difficult to manage or the baby is growing too large, your healthcare team may advise an earlier delivery (e.g., at 38 weeks)
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39 week
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Birth weight
Periodo de tiempo: 39 week
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Babies born to mothers with Gestational Diabetes Mellitus (GDM) most frequently have higher-than-average birth weights (often between 3.2 kg and 3.7 kg), but can range anywhere from being larger than normal to smaller than average, depending on blood sugar management and placental health.
1. Macrosomia (Large for Gestational Age - LGA)Definition: Birth weight greater than 4.0 kg or above the 90th percentile for gestational age.IRisk: High birth weight can cause delivery complications, including shoulder dystocia (where the baby's shoulder gets stuck in the birth canal), and often requires a Cesarean section.2.
Small for Gestational Age (SGA)Definition: Birth weight below the 10th percentile for gestational age.Incidence: .Risk: While less common than large size, impaired fetal growth can happen, particularly if the GDM causes complications with placental blood flow later in the pregnancy.
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39 week
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Apgar score
Periodo de tiempo: 39 week
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The Apgar score is a rapid, standardized assessment used to evaluate a newborn's health immediately after birth.
It determines how well the baby tolerated the birthing process and how they are adjusting to life outside the womb.
How It Is ScoredMedical staff assess five criteria (summarized by the mnemonic APGAR).
Each criterion is assigned 0, 1, or 2 points.A - Appearance (Skin Color): 0 = Pale or blue; 1 = Pink body with blue extremities; 2 = Completely pink.P - Pulse (Heart Rate): 0 = Absent; 1 = Below 100 bpm; 2 = Above 100 bpm.G - Grimace (Reflex Irritability): 0 = No response; 1 = Grimace or weak cry to stimulation; 2 = Vigorous cry, sneeze, or cough.A - Activity (Muscle Tone): 0 = Limp or floppy; 1 = Some arm and leg flexion; 2 = Active, spontaneous movement.R - Respiration (Breathing): 0 = Absent; 1 = Slow, irregular, or weak cry; 2 = Strong, lusty cry.
Understanding the Results:7 to 10: Reassuring (normal).4 to 6: Moderately abnormal.0 to 3: Critically low
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39 week
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Rate of neonatal intensive care unit admission
Periodo de tiempo: 39 week
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NICU admission rates and criteria vary based on location, gestational age, and specific birth circumstances.Conditions like gestational diabetes, pregnancy-induced hypertension (PIH), or infections (e.g., sepsis) frequently trigger the need for immediate newborn intensive care
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39 week
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jawaria Iftikhar, phd*, Riphah International University
- Director de estudio: Akbar Waheed, PHD, Riphah International University
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)
29 de julio de 2026
Finalización primaria (Estimado)
1 de junio de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
8 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de junio de 2026
Publicado por primera vez (Actual)
12 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades del sistema endocrino
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades metabólicas
- Complicaciones del embarazo
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Enfermedades Nutricionales y Metabólicas
- Diabetes Gestacional
- Químicos orgánicos
- Biguanides
- Guanidinas
- Amidinos
- Metformina
Otros números de identificación del estudio
- IIMC/IRB/26/1037 Jawaria
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .