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Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus

29 juillet 2026 mis à jour par: Riphah International University
  1. 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.
  2. To compare the effects of metformin, insulin, and their combination with multistrain probiotics on inflammatory biomarkers in women with GDM.
  3. 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

200

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Pakistan
    • Punjab Province
      • Rawalpindi, Punjab Province, Pakistan, 46000

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: GRP 1 Tab metformin
Autre: GRP 1 Tab metformin
Tab metformin 500 mg TDS for 12 weeks
Comparateur actif: GRP 2 Inj insulin
Autre: GRP 2 Inj insulin
Inj insulin s/c BD for 12 weeks
Expérimental: GRP 3 Tab metformin + HI flora sachet
Autre: GRP 3 Tab metformin + HI flora sachet
Tab metformin 500 mg TDS + HI flora sachet OD for 12 weeks
Expérimental: GRP 4 Inj insulin + HI flora
Autre: GRP 4 Inj insulin + HI flora sachet
Inj insulin s/c BD + HI flora sachet OD for 12 weeks

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Fasting blood glucose levels
Délai: 12 week
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.
12 week
Fasting Serum Insulin Levels
Délai: 12 week
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"
12 week
Homeostatic Model Assessment of Insulin Resistance
Délai: 12 week
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)
12 week
Glycated Hemoglobin
Délai: 12 week
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)
12 week

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
High-sensitivity C-reactive protein
Délai: 12 week
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/
12 week
Neutrophil-to-Lymphocyte ratio
Délai: 12 week
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
12 week
Adiponectin
Délai: 12 week
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.
12 week
fetal Abdominal Circumference
Délai: 12 week
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
12 week
thickness of placenta
Délai: 12 week
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).
12 week
Amniotic Fluid Index
Délai: 12 week
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.
12 week
Gestational age at delivery
Délai: 39 weeks
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.
39 weeks
Mode of delivery
Délai: 39 week
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)
39 week
Birth weight
Délai: 39 week
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.
39 week
Apgar score
Délai: 39 week
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
39 week
Rate of neonatal intensive care unit admission
Délai: 39 week
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
39 week

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Riphah International University

Les enquêteurs

  • Chercheur principal: Jawaria Iftikhar, phd*, Riphah International University
  • Directeur d'études: Akbar Waheed, PHD, Riphah International University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

29 juillet 2026

Achèvement primaire (Estimé)

1 juin 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

8 juin 2026

Première soumission répondant aux critères de contrôle qualité

8 juin 2026

Première publication (Réel)

12 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IIMC/IRB/26/1037 Jawaria

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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