NCT06840613

Brief 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). 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 17, 2025

Last Update Submit

February 22, 2025

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

GDMDiabetes MellitusPregnancyGlycemic Control

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and up to 12 weeks

Study Arms (2)

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.

Other: Myo-InositolOther: 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.

Other: Glucophage

Interventions

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

Glucophage Plus Myo-Inositol
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.

Glucophage AloneGlucophage Plus Myo-Inositol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 35 years and Singleton pregnancy
  • GDM diagnosed during pregnancy as per operational definition
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus

Interventions

InositolMetformin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesBiguanidesGuanidinesAmidines

Central Study Contacts

Dr. Hifza Rasheed

CONTACT

+923338377083hifzarasheed26@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 21, 2025

Study Start

March 1, 2025

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02