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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes, Inflammation, Metabolic Syndrome, Glucose Intolerance During Pregnancy, Glucose Intolerance, Insulin Resistance

Intervention / Treatment
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* Other: Very low carbohydrate dietary intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>The no intervention arm will not receive counselling but will follow their routine diet suggested during their routine antenatal visits. | |
| Experimental: Intervention<br>The intervention arm will be counselled about very low carbohydrate diet (<10%carbohydrate) | Other: Very low carbohydrate dietary intervention<br>* The experimental group will be counseled about very low carbohydrate diet i.e., <10% carbohydrate,40-50% protein and lipid in diet).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asses change in Fasting blood glucose |  | 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 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 HOMA-IR |  | Baseline after one month and two month | 
| Asses change in Adiponectin |  | Baseline after one month and two month | 
| Carboxymethyl-lysine |  | Baseline after one month and two month | 
| Asses change in C-reactive protein |  | Baseline after one month and two month | 
| Asses change in NFk |  | Baseline after one month and two month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes, insulin resistance, carbohydrate, inflammation, glucose intolerance