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

NCT05305352 | Withdrawn DMC

• 1 other identifier: DIR/KMU-AS&RB/EV/001551
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

gestational diabetes; insulin resistance; carbohydrate; inflammation; glucose intolerance

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

No intervention

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Other: Very low carbohydrate dietary intervention

Interventions

Very low carbohydrate dietary intervention OTHER

The experimental group will be counseled about very low carbohydrate diet i.e., \<10% carbohydrate,40-50% protein and lipid in diet).

Intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• nd trimester women with GDM
• Either taking or not taking oral hypoglycemic agent or insulin

You may not qualify if:

• Previously known type 1 or type 2 Diabetic patients
• Age less than 18 and above 40 years
• Any other chronic disease

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead

Study Sites (1)

Khyber Medical University

Peshawar, KPK, 25100, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 27182173 BACKGROUND

• 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.

  PMID: 23564917 BACKGROUND

• 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.

  PMID: 32024026 BACKGROUND

• 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.

  PMID: 9540949 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Inflammation; Metabolic Syndrome; Glucose Intolerance; Insulin Resistance

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Hyperglycemia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 31, 2022
• Study Start: January 1, 2025
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)