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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05305352
• Other study ID #: DIR/KMU-AS&RB/EV/001551
• Status: Suspended
• Phase: N/A
• Start date: January 2024
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: Khyber Medical University Peshawar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Very 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).

Locations

Country	Name	City	State
Pakistan	Khyber Medical University	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Major CA, Henry MJ, De Veciana M, Morgan MA. The effects of carbohydrate restriction in patients with diet-controlled gestational diabetes. Obstet Gynecol. 1998 Apr;91(4):600-4. doi: 10.1016/s0029-7844(98)00003-9. — View Citation

Moreno-Castilla C, Hernandez M, Bergua M, Alvarez MC, Arce MA, Rodriguez K, Martinez-Alonso M, Iglesias M, Mateu M, Santos MD, Pacheco LR, Blasco Y, Martin E, Balsells N, Aranda N, Mauricio D. Low-carbohydrate diet for the treatment of gestational diabetes mellitus: a randomized controlled trial. Diabetes Care. 2013 Aug;36(8):2233-8. doi: 10.2337/dc12-2714. Epub 2013 Apr 5. — View Citation

Mustad VA, Huynh DTT, Lopez-Pedrosa JM, Campoy C, Rueda R. The Role of Dietary Carbohydrates in Gestational Diabetes. Nutrients. 2020 Jan 31;12(2):385. doi: 10.3390/nu12020385. — View Citation

Trout KK, Homko CJ, Wetzel-Effinger L, Mulla W, Mora R, McGrath J, Basel-Brown L, Arcamone A, Sami P, Makambi KH. Macronutrient Composition or Social Determinants? Impact on Infant Outcomes With Gestational Diabetes Mellitus. Diabetes Spectr. 2016 May;29(2):71-8. doi: 10.2337/diaspect.29.2.71. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asses change in Fasting blood glucose		Baseline after one month and two month
Primary	Asses change in Postprandial glucose		Baseline after one month and two month
Primary	Asses change in Glycated hemoglobin A1c (HbA1c)		Baseline after one month and two month
Primary	Asses change in Lean and fat body mass		Baseline after one month and two month
Primary	Asses change in Fasting insulin		Baseline after one month and two month
Primary	Asses change in HOMA-IR		Baseline after one month and two month
Primary	Asses change in Adiponectin		Baseline after one month and two month
Primary	Carboxymethyl-lysine		Baseline after one month and two month
Primary	Asses change in C-reactive protein		Baseline after one month and two month
Primary	Asses change in NFk		Baseline after one month and two month