Glucophage Plus Myo-Inositol vs Glucophage in Glycemic Control Among Patients With Gestational Diabetes Mellitus
NCT ID: NCT06840613
Last Updated: 2025-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-03-31
2025-05-31
Brief Summary
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Detailed Description
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Gestational diabetes mellitus (GDM) is a condition characterized by glucose intolerance that is first recognized during pregnancy, posing significant health risks for both the mother and fetus. Despite various treatment approaches, achieving optimal glycemic control remains a challenge. While Glucophage (Metformin) is widely used for managing GDM, Myo-Inositol has gained attention for its potential role in improving insulin sensitivity and reducing the need for additional pharmacological interventions.
Study Design and Methodology:
This study will enroll 90 participants aged 18-35 years with singleton pregnancies diagnosed with GDM between 22-32 weeks of gestation.
Participants will be randomly assigned to one of two intervention groups:
Experimental Group (Group A): Patients will receive 2000 mg Myo-Inositol (two capsules) with 500 mg Glucophage, three times a day.
Control Group (Group B): Patients will receive 500 mg Glucophage, three times a day.
All participants will be educated on lifestyle modifications and dietary control, and their blood glucose levels will be monitored throughout the study.
Data will be collected at baseline and at multiple time points during pregnancy to assess glycemic control, the need for insulin therapy, and any adverse effects associated with the interventions.
Rationale for the Study:
Myo-Inositol is an insulin-sensitizing agent that plays a crucial role in glucose metabolism. Emerging evidence suggests that Myo-Inositol supplementation may reduce insulin resistance, lower blood glucose levels, and decrease the likelihood of requiring insulin therapy. By comparing its effects in combination with Glucophage, this study aims to determine whether Myo-Inositol can serve as an effective adjunct therapy for managing GDM.
Expected Outcomes and Implications:
Primary Outcome: Improved glycemic control as measured by fasting and postprandial blood glucose levels.
Secondary Outcomes: Reduction in the number of patients requiring insulin therapy, delayed initiation of insulin if needed, and improved maternal and fetal outcomes.
The results of this study could help shape future clinical guidelines for GDM management, offering a non-invasive, cost-effective alternative to conventional treatment approaches.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glucophage Plus Myo-Inositol
Intervention: Patients in this group will receive 2 capsules of Myo-Inositol (2000 mg each) along with 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
Myo-Inositol
Intervention: Patients in this group will receive 2 capsules of Myo-Inositol (2000 mg each) along with 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment
Glucophage
Intervention: Patients in this group will receive 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
Glucophage Alone
Intervention: Patients in this group will receive 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
Glucophage
Intervention: Patients in this group will receive 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
Interventions
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Myo-Inositol
Intervention: Patients in this group will receive 2 capsules of Myo-Inositol (2000 mg each) along with 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment
Glucophage
Intervention: Patients in this group will receive 500 mg Glucophage three times a day.
Monitoring: Blood glucose levels will be measured at baseline and after treatment.
Eligibility Criteria
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Inclusion Criteria
* GDM diagnosed during pregnancy as per operational definition
* 22 to 32 weeks of gestation
* No more than 35 days after GDM diagnosis
* BMI of 18 to 29
* Capacity for self-monitoring of blood glucose
Exclusion Criteria
* Already taking insulin during this pregnancy or oral hypoglycemic agents
* Patients taking long time corticosteroid treatment
* Patients with history of pre-existing diabetes
* Overt diabetes diagnosed during pregnancy, i.e. fasting plasma glucose ≥ 126 mg/dL (7 mmol/l) and/or 2-hour post OGTT plasma glucose value ≥ 200 mg/dL (11.1 mmol)
* History of any bariatric surgery
* Twin pregnanc
18 Years
35 Years
FEMALE
No
Sponsors
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University of Health Sciences Lahore
OTHER
Responsible Party
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Hifza Rasheed
Principal Investigator
Central Contacts
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Other Identifiers
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Exp129
Identifier Type: -
Identifier Source: org_study_id
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