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ROLE OF DIET ON BLOOD GLUCOSE CONTROL IN PREGNANT WOMEN WITH GESTATIONAL DIABETES MELLITUS USING CONTINUOUS GLUCOSE MONITORING AND GENETIC TESTING.

Effect of Dietary Intervention on Glycemic Control in Pregnant Women with Gestational Diabetes Mellitus: A Controlled clinical study with Continuous Glucose Monitorong and Genetic correlation. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/110212
Enrollment
100
Registered
2026-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O098- Supervision of other high risk pregnancies

Interventions

Intervention1: PARTIALLY HYDROLYSED GUAR GUM(6.2g/serve), SPLIT MEAL, FOOD ORDER ALONG WITH DIETARY COUNSELING BASED ON STANDARD CLINICAL GUIDELINE.: PHGG is a prebiotic soluble dietary fiber derived

Sponsors

University Grants Commission
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: OGTT Blood glucose value 2h PPPG greater than or equal to 140 mg per dl for experimental group. Blood glucose less than 140 mg per dl for genetic case control and interventional control group. Planning to attend the same tertiary care hospital for their rest of the pregnancy. All three trimesters Singleton pregnancy, primiparous, multiparous women, natural conception, pregnancies achieved through Assisted Reproductive Technology All classes of BMI Blood pressure category- normal systolic mm hg less than 120 and diastolic less than 80 mm hg elevated 120-129 and less than 80, stage 1 130-139 or 80-89. Willing to participate in the study.

Exclusion criteria

Exclusion criteria: Pre-existing diabetes : Type 1 & Type 2 Diabetes mellitus. Chronic hypertension, heart diseases, thyroid disorders, severe liver or kidney diseases (including intrahepatic cholestasis of pregnancy, autoimmune hepatitis, nephrotic syndrome, chronic glomerular nephritis, IgA nephropathy). Autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, primary Sjogren syndrome), any chronic illness (cancer, tuberculosis), severely ill at commencement of the study. Medications that might affect their glucose metabolism steroids, beta-adrenergic agonist, anti- psychotic drugs)-can be a confounding factor for evaluating the effectiveness of the intervention. any gastrointestinal complications, Not willing to participate in the study. Previously given birth to child with in-born error metabolism. Bad obstetric history.

Design outcomes

Primary

MeasureTime frame
1.To evaluate the effect of a 2-week dietary intervention on blood glucose levels in pregnant women with gestational diabetes mellitus using Continuous Overall Net Glycemic action and Mean Amplitude of Glycemic Excursion calculations from Continuous Glucose Monitoring. 2. To Understand the prevalence of nuclear and mitochondrial mutations MT-TL1, TCF7L2, IRS1 through genetic testing among the women screened in the hospital, Chennai. 3. Correlation of Neck circumference , Triglyceride-glucose index with Gestation Diabetes Mellitus to predict it early.Timepoint: 2 months

Secondary

MeasureTime frame
1. To assess the correlation between specific gene mutations with glycaemic response to dietary intervention. 2. To assess maternal and fetal outcomes in the participants 3. To assess maternal diabetic status after 3 month of delivery in the study group. Timepoint: 13 months

Countries

India

Contacts

Public ContactS Tamil Malar

Meenakshi Academy of Higher Education and Research

srikumaripavithra@gmail.com8056253066

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026