Very Low Carbohydrate Dietary Intervention in Gestational Diabetes Mellitus: Effect on Glycemic, Metabolic, Glycated and Inflammatory Marker: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gestational Diabetes
- Sponsor
- Khyber Medical University Peshawar
- Locations
- 1
- Primary Endpoint
- Asses change in Adiponectin
- Status
- Withdrawn
- Last Updated
- last year
Overview
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.
Investigators
Bibi Hajira
Assistant Professor
Khyber Medical University Peshawar
Eligibility Criteria
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
Outcomes
Primary Outcomes
Asses change in Adiponectin
Time Frame: Baseline after one month and two month
Carboxymethyl-lysine
Time Frame: Baseline after one month and two month
Asses change in NFk
Time Frame: Baseline after one month and two month
Asses change in Postprandial glucose
Time Frame: Baseline after one month and two month
Asses change in Glycated hemoglobin A1c (HbA1c)
Time Frame: Baseline after one month and two month
Asses change in Fasting blood glucose
Time Frame: Baseline after one month and two month
Asses change in HOMA-IR
Time Frame: Baseline after one month and two month
Asses change in Lean and fat body mass
Time Frame: Baseline after one month and two month
Asses change in Fasting insulin
Time Frame: Baseline after one month and two month
Asses change in C-reactive protein
Time Frame: Baseline after one month and two month