Gestational Diabetes, Glucose Intolerance, Glucose Intolerance During Pregnancy, Inflammation, Insulin Resistance, Metabolic Syndrome
Conditions
Keywords
gestational diabetes, insulin resistance, carbohydrate, inflammation, glucose intolerance
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.
Interventions
OTHERVery 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).
Sponsors
Khyber Medical University Peshawar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Countries
Pakistan
Outcome results
None listed