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

Not Applicable

Withdrawn

• Conditions: Glucose Intolerance During Pregnancy; Metabolic Syndrome; Insulin Resistance; Inflammation; Gestational Diabetes; Glucose Intolerance
• Interventions: Other: Very low carbohydrate dietary intervention

• Registration Number: NCT05305352
• Lead Sponsor: Khyber Medical University Peshawar

Brief 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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-22
• Study First Posted: 2022-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Study Start: 2025-01
• Primary Completion: 2025-02
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• 2nd trimester women with GDM
• Either taking or not taking oral hypoglycemic agent or insulin

Exclusion Criteria

• Previously known type 1 or type 2 Diabetic patients
• Age less than 18 and above 40 years
• Any other chronic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Very low carbohydrate dietary intervention	The intervention arm will be counselled about very low carbohydrate diet (\<10%carbohydrate)

Primary Outcome Measures

Name	Time	Method
Asses change in Adiponectin	Baseline after one month and two month
Carboxymethyl-lysine	Baseline after one month and two month
Asses change in NFk	Baseline after one month and two month
Asses change in Postprandial glucose	Baseline after one month and two month
Asses change in Glycated hemoglobin A1c (HbA1c)	Baseline after one month and two month
Asses change in Fasting blood glucose	Baseline after one month and two month
Asses change in HOMA-IR	Baseline after one month and two month
Asses change in Lean and fat body mass	Baseline after one month and two month
Asses change in Fasting insulin	Baseline after one month and two month
Asses change in C-reactive protein	Baseline after one month and two month

Trial Locations

Locations (1)

Khyber Medical University; 🇵🇰 Peshawar, KPK, Pakistan