Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
2026年7月29日 更新者：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.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
200
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jawaria Iftikhar, phd*
- 電話番号：03004219529
- メール：jawaria.iftikhar@riphah.edu.pk
研究場所
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-
Punjab Province
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Rawalpindi、Punjab Province、パキスタン、46000
- 募集
- Pakistan Railway Hospital
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コンタクト：
- Jawaria Iftikhar, PHD*
- 電話番号：923004219529
- メール：jawaria.iftikhar@riphah.edu.pk
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：GRP 1 Tab metformin
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Tab metformin 500 mg TDS for 12 weeks
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アクティブコンパレータ：GRP 2 Inj insulin
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Inj insulin s/c BD for 12 weeks
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fasting blood glucose levels
時間枠：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
時間枠：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"
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12 week
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Homeostatic Model Assessment of Insulin Resistance
時間枠：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)
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12 week
|
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Glycated Hemoglobin
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
High-sensitivity C-reactive protein
時間枠：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/
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12 week
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Neutrophil-to-Lymphocyte ratio
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
12 week
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Gestational age at delivery
時間枠：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.
|
39 weeks
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Mode of delivery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
39 week
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Jawaria Iftikhar, phd*、Riphah International University
- スタディディレクター：Akbar Waheed, PHD、Riphah International University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月29日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年6月8日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月30日
QC基準を満たした最後の更新が送信されました
2026年7月29日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。