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

Khyber Medical University Peshawar

Status: Withdrawn

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

Treatments: Other: Very low carbohydrate dietary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05305352

DIR/KMU-AS&RB/EV/001551

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

No intervention

No Intervention group

Description:

The no intervention arm will not receive counselling but will follow their routine diet suggested during their routine antenatal visits.

Intervention

Experimental group

Description:

The intervention arm will be counselled about very low carbohydrate diet (\<10%carbohydrate)

Treatment:

Other: Very low carbohydrate dietary intervention