Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
2026년 7월 29일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
200
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jawaria Iftikhar, phd*
- 전화번호: 03004219529
- 이메일: jawaria.iftikhar@riphah.edu.pk
연구 장소
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Punjab Province
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Rawalpindi, Punjab Province, 파키스탄, 46000
- 모병
- Pakistan Railway Hospital
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연락하다:
- Jawaria Iftikhar, PHD*
- 전화번호: 923004219529
- 이메일: jawaria.iftikhar@riphah.edu.pk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: GRP 1 Tab metformin
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Tab metformin 500 mg TDS for 12 weeks
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활성 비교기: GRP 2 Inj insulin
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Inj insulin s/c BD for 12 weeks
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실험적: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fasting blood glucose levels
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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High-sensitivity C-reactive protein
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Jawaria Iftikhar, phd*, Riphah International University
- 연구 책임자: Akbar Waheed, PHD, Riphah International University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 7월 29일
기본 완료 (추정된)
2027년 6월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 6월 8일
QC 기준을 충족하는 최초 제출
2026년 6월 8일
처음 게시됨 (실제)
2026년 6월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 29일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IIMC/IRB/26/1037 Jawaria
개별 참가자 데이터(IPD) 계획
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아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .