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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Inflammation; Metabolic Syndrome; Insulin Resistance; Glucose Intolerance; Gestational Diabetes; Glucose Intolerance During Pregnancy
• Intervention / Treatment: Other: Very low carbohydrate dietary intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan, 25100
      • Khyber Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; The no intervention arm will not receive counselling but will follow their routine diet suggested during their routine antenatal visits.
Experimental: Intervention; The intervention arm will be counselled about very low carbohydrate diet (<10%carbohydrate)	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).

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Khyber Medical University Peshawar

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: inflammation; insulin resistance; gestational diabetes; glucose intolerance; carbohydrate
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Pregnancy Complications; Hyperglycemia; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Inflammation; Metabolic Syndrome; Glucose Intolerance; Insulin Resistance; Diabetes, Gestational
• Other Study ID Numbers: DIR/KMU-AS&RB/EV/001551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No