Gestational Diabetes Mellitus (GDM)NCT06840613
Glucophage Plus Myo-Inositol vs Glucophage in Glycemic Control Among Patients With Gestational Diabetes Mellitus
A study testing Myo-Inositol and Glucophage in people with Gestational Diabetes Mellitus (GDM), run by University of Health Sciences Lahore.
Trial summary
This randomized controlled trial aims to compare the efficacy of Glucophage plus Myo-Inositol versus Glucophage alone in glycemic control among patients with gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- Myo-Inositol and Glucophage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to May 2025
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 35 years and Singleton pregnancy
- 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
Who cannot join
- Patients with obesity BMI more than or equal to 30.
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Glucophage Plus Myo-Inositol Versus Glucophage in Terms of Glycemic Control Among Patients With Gestational Diabetes Mellitus
This randomized controlled trial aims to compare the efficacy of Glucophage plus Myo-Inositol versus Glucophage alone in glycemic control among patients with gestational diabetes mellitus (GDM). The study will assess whether the addition of Myo-Inositol improves glycemic control and reduces insulin requirements in GDM patients. Participants will be randomized into two groups: one receiving Myo-Inositol in combination with Glucophage and the other receiving Glucophage alone. The primary outcome will be glycemic control as assessed by fasting and postprandial glucose levels. Secondary outcomes include insulin requirement and gestational age at initiation of insulin therapy.
Read the detailed description
This prospective, single-center, randomized controlled trial is designed to evaluate the efficacy of Myo-Inositol supplementation in combination with Glucophage compared to Glucophage alone for glycemic control in women diagnosed with gestational diabetes mellitus (GDM). The trial will be conducted at SIMS/Services Hospital Lahore under the supervision of the University of Health Sciences Lahore.
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
- Gestational Diabetes Mellitus (GDM)
- Being tested
- Myo-Inositol, Glucophage
- Keywords
- GDM, Diabetes Mellitus, Pregnancy, Glycemic Control
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myo-InositolOther
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
GlucophageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Glucophage Plus Myo-Inositol | Active comparator | 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. Receives: Other: Myo-Inositol; Other: Glucophage |
| Glucophage Alone | Active comparator | 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. Receives: Other: Glucophage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control
Glycemic control is defined as fasting glucose <95 mg/dL and postprandial glucose <120 mg/dL.
Blood glucose levels will be recorded at follow-up visit
Measured: Baseline and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hifza Rasheed, University of Health Sciences Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840613
- Sponsor's protocol ID
- Exp129
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Glucophage Plus Myo-Inositol Versus Glucophage in Terms of Glycemic Control Among Patients With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06840613
- Acronym / sponsor ID
- Exp129
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- GDM, Diabetes Mellitus, Pregnancy, Glycemic Control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 21 Feb 2025 (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.
This randomized controlled trial aims to compare the efficacy of Glucophage plus Myo-Inositol versus Glucophage alone in glycemic control among patients with gestational diabetes mellitus (GDM). The study will assess whether the addition of Myo-Inositol improves glycemic control and reduces insulin requirements in GDM patients. Participants will be randomized into two groups: one receiving Myo-Inositol in combination with Glucophage and the other receiving Glucophage alone. The primary outcome will be glycemic control as assessed by fasting and postprandial glucose levels. Secondary outcomes include insulin requirement and gestational age at initiation of insulin therapy.
Detailed description
This prospective, single-center, randomized controlled trial is designed to evaluate the efficacy of Myo-Inositol supplementation in combination with Glucophage compared to Glucophage alone for glycemic control in women diagnosed with gestational diabetes mellitus (GDM). The trial will be conducted at SIMS/Services Hospital Lahore under the supervision of the University of Health Sciences Lahore.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucophage Plus Myo-Inositol | Active comparator | Other: Myo-Inositol, Other: GlucophageIntervention: 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 Alone | Active comparator | Other: GlucophageIntervention: 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 35 years and Singleton pregnancy
- 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
Key exclusion criteria (7 listed)
- Patients with obesity BMI more than or equal to 30.
- 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)
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 |
|---|---|---|
| Myo-InositolIntervention: 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 | Other | Glucophage Plus Myo-Inositol |
| GlucophageIntervention: 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. | Other | Glucophage Alone, Glucophage Plus Myo-Inositol |
Primary outcome
Glycemic Control
Time frame: Baseline and up to 12 weeks
Glycemic control is defined as fasting glucose <95 mg/dL and postprandial glucose <120 mg/dL. Blood glucose levels will be recorded at follow-up visit
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 25 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Myo-Inositol and Glucophage in people with Gestational Diabetes Mellitus (GDM), run by University of Health Sciences Lahore.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Dr. Hifza Rasheed (+923338377083, hifzarasheed26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (time frame: Baseline and up to 12 weeks). 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 25 Feb 2025.