Gestational DiabetesNCT07645001
Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
A study testing GRP 1 Tab metformin, GRP 2 Inj insulin and GRP 3 Tab metformin + HI flora sachet in people with Gestational Diabetes, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- GRP 1 Tab metformin, GRP 2 Inj insulin and GRP 3 Tab metformin + HI flora sachet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jul 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Pakistan Railway Hospital
Rawalpindi, Punjab Province, 46000
Jawaria Iftikhar, PHD*, 923004219529, jawaria.iftikhar@riphah.edu.pk
About this study
- 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.
- Conditions
- Gestational Diabetes
- Being tested
- GRP 1 Tab metformin, GRP 2 Inj insulin, GRP 3 Tab metformin + HI flora sachet, GRP 4 Inj insulin + HI flora sachet
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRP 1 Tab metforminOther
Tab metformin 500 mg TDS for 12 weeks
GRP 2 Inj insulinOther
Inj insulin s/c BD for 12 weeks
GRP 3 Tab metformin + HI flora sachetOther
Tab metformin 500 mg TDS + HI flora sachet OD for 12 weeks
GRP 4 Inj insulin + HI flora sachetOther
Inj insulin s/c BD + HI flora sachet OD for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| GRP 1 Tab metformin | Active comparator | Not described Receives: Other: GRP 1 Tab metformin |
| GRP 2 Inj insulin | Active comparator | Not described Receives: Other: GRP 2 Inj insulin |
| GRP 3 Tab metformin + HI flora sachet | Experimental | Not described Receives: Other: GRP 3 Tab metformin + HI flora sachet |
| GRP 4 Inj insulin + HI flora | Experimental | Not described Receives: Other: GRP 4 Inj insulin + HI flora sachet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose levels
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.
Measured: 12 week
Fasting Serum Insulin Levels
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"
Measured: 12 week
Homeostatic Model Assessment of Insulin Resistance
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)
Measured: 12 week
Glycated Hemoglobin
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)
Measured: 12 week
Secondary outcomes (11)
High-sensitivity C-reactive protein
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/
Measured: 12 week
Neutrophil-to-Lymphocyte ratio
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
Measured: 12 week
Adiponectin
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.
Measured: 12 week
fetal Abdominal Circumference
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
Measured: 12 week
thickness of placenta
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).
Measured: 12 week
Amniotic Fluid Index
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.
Measured: 12 week
Gestational age at delivery
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.
Measured: 39 weeks
Mode of delivery
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)
Measured: 39 week
Birth weight
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.
Measured: 39 week
Apgar score
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
Measured: 39 week
Rate of neonatal intensive care unit admission
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
Measured: 39 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start29 Jul 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jawaria Iftikhar, phd*, Principal investigator, Riphah International UniversityAkbar Waheed, PHD, Study director, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645001
- Sponsor's protocol ID
- IIMC/IRB/26/1037 Jawaria
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Synergy of Probiotic Augmented Conventional Antidiabetic Pharmacotherapy in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07645001
- Acronym / sponsor ID
- IIMC/IRB/26/1037 Jawaria
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GRP 1 Tab metformin | Active comparator | Other: GRP 1 Tab metformin |
| GRP 2 Inj insulin | Active comparator | Other: GRP 2 Inj insulin |
| GRP 3 Tab metformin + HI flora sachet | Experimental | Other: GRP 3 Tab metformin + HI flora sachet |
| GRP 4 Inj insulin + HI flora | Experimental | Other: GRP 4 Inj insulin + HI flora sachet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRP 1 Tab metforminTab metformin 500 mg TDS for 12 weeks | Other | GRP 1 Tab metformin |
| GRP 2 Inj insulinInj insulin s/c BD for 12 weeks | Other | GRP 2 Inj insulin |
| GRP 3 Tab metformin + HI flora sachetTab metformin 500 mg TDS + HI flora sachet OD for 12 weeks | Other | GRP 3 Tab metformin + HI flora sachet |
| GRP 4 Inj insulin + HI flora sachetInj insulin s/c BD + HI flora sachet OD for 12 weeks | Other | GRP 4 Inj insulin + HI flora |
Primary outcome
Fasting blood glucose levels
Time frame: 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.
Fasting Serum Insulin Levels
Time frame: 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"
Homeostatic Model Assessment of Insulin Resistance
Time frame: 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)
Glycated Hemoglobin
Time frame: 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)
11 secondary outcomes
High-sensitivity C-reactive protein
Time frame: 12 week
Neutrophil-to-Lymphocyte ratio
Time frame: 12 week
Adiponectin
Time frame: 12 week
fetal Abdominal Circumference
Time frame: 12 week
thickness of placenta
Time frame: 12 week
Amniotic Fluid Index
Time frame: 12 week
Gestational age at delivery
Time frame: 39 weeks
Mode of delivery
Time frame: 39 week
Birth weight
Time frame: 39 week
Apgar score
Time frame: 39 week
Rate of neonatal intensive care unit admission
Time frame: 39 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jawaria Iftikhar, phd* principal investigator
Riphah International University
Akbar Waheed, PHD study director
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRP 1 Tab metformin, GRP 2 Inj insulin and GRP 3 Tab metformin + HI flora sachet in people with Gestational Diabetes, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jawaria Iftikhar, phd* (03004219529, jawaria.iftikhar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose levels (time frame: 12 week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.