NCT05305352

Effect of Very Low Carbohydrate Diet on Glycemic, Metabolic, Glycated and Inflammatory Markers in Gestational Diabetes Mellitus

Very Low Carbohydrate Dietary Intervention in Gestational Diabetes Mellitus: Effect on Glycemic, Metabolic, Glycated and Inflammatory Marker: A Randomized Controlled Trial

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Khyber Medical University Peshawar · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Uncontrolled Gestational Diabetes Mellitus may leads to maternal and fetal complications. These complications can be avoided by adopting the dietary modifications along with medications. Previous studies suggested that consumption of low Carbohydrate diet improves Gestational Diabetes and related complications. Therefore, this study aims to investigate the effect of very low carbohydrate dietary intervention on glycemic, glycemic, metabolic, glycated and inflammatory markers.

Detailed description

This will be randomized controlled trial of 80-100 Gestational diabetic women of second trimester to investigate the effect of very low carbohydrate dietary intervention on glycemic, metabolic, glycated and inflammatory markers. Subjects will be recruited from ob/gyn outpatient of different hospitals. Eligible subjects will be enrolled in the study and will be allocated into two groups. One will be intervention and other will be control group. At baseline fasting blood samples from both group will be taken and will be analyzed for different biomarkers. Thereafter, the experimental group will be counseled about their modified diet (very low carbohydrate diet \<10%,40-50% protein and lipid in diet). Control group will be allowed to continue their routine diet counselled as part of their antenatal care.

Conditions

• Gestational Diabetes
• Inflammation
• Metabolic Syndrome
• Glucose Intolerance During Pregnancy
• Glucose Intolerance
• Insulin Resistance

Interventions

Type	Name	Description
OTHER	Very low carbohydrate dietary intervention	The experimental group will be counseled about very low carbohydrate diet i.e., \<10% carbohydrate,40-50% protein and lipid in diet).

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-02-01
• Completion: 2025-07-01
• First posted: 2022-03-31
• Last updated: 2024-07-25

Locations

1 site across 1 country: Pakistan