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

Primary Purpose

Gestational Diabetes, Inflammation, Metabolic Syndrome

Status
Suspended
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Very low carbohydrate dietary intervention
Sponsored by
Khyber Medical University Peshawar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes focused on measuring gestational diabetes, insulin resistance, carbohydrate, inflammation, glucose intolerance

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Khyber Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No intervention

Intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Asses change in Fasting blood glucose
Asses change in Postprandial glucose
Asses change in Glycated hemoglobin A1c (HbA1c)
Asses change in Lean and fat body mass
Asses change in Fasting insulin
Asses change in HOMA-IR
Asses change in Adiponectin
Carboxymethyl-lysine
Asses change in C-reactive protein
Asses change in NFk

Secondary Outcome Measures

Full Information

First Posted
February 28, 2022
Last Updated
April 6, 2023
Sponsor
Khyber Medical University Peshawar
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1. Study Identification

Unique Protocol Identification Number
NCT05305352
Brief Title
Effect of Very Low Carbohydrate Diet on Glycemic, Metabolic, Glycated and Inflammatory Markers in Gestational Diabetes Mellitus
Official Title
Very Low Carbohydrate Dietary Intervention in Gestational Diabetes Mellitus: Effect on Glycemic, Metabolic, Glycated and Inflammatory Marker: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Due to less number of participants willing to participate.
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khyber Medical University Peshawar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Inflammation, Metabolic Syndrome, Glucose Intolerance During Pregnancy, Glucose Intolerance, Insulin Resistance
Keywords
gestational diabetes, insulin resistance, carbohydrate, inflammation, glucose intolerance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
The no intervention arm will not receive counselling but will follow their routine diet suggested during their routine antenatal visits.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The intervention arm will be counselled about very low carbohydrate diet (<10%carbohydrate)
Intervention Type
Other
Intervention Name(s)
Very low carbohydrate dietary intervention
Intervention Description
The experimental group will be counseled about very low carbohydrate diet i.e., <10% carbohydrate,40-50% protein and lipid in diet).
Primary Outcome Measure Information:
Title
Asses change in Fasting blood glucose
Time Frame
Baseline after one month and two month
Title
Asses change in Postprandial glucose
Time Frame
Baseline after one month and two month
Title
Asses change in Glycated hemoglobin A1c (HbA1c)
Time Frame
Baseline after one month and two month
Title
Asses change in Lean and fat body mass
Time Frame
Baseline after one month and two month
Title
Asses change in Fasting insulin
Time Frame
Baseline after one month and two month
Title
Asses change in HOMA-IR
Time Frame
Baseline after one month and two month
Title
Asses change in Adiponectin
Time Frame
Baseline after one month and two month
Title
Carboxymethyl-lysine
Time Frame
Baseline after one month and two month
Title
Asses change in C-reactive protein
Time Frame
Baseline after one month and two month
Title
Asses change in NFk
Time Frame
Baseline after one month and two month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Khyber Medical University
City
Peshawar
State/Province
KPK
ZIP/Postal Code
25100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27182173
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.
Results Reference
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PubMed Identifier
23564917
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.
Results Reference
background
PubMed Identifier
32024026
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.
Results Reference
background
PubMed Identifier
9540949
Citation
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.
Results Reference
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Effect of Very Low Carbohydrate Diet on Glycemic, Metabolic, Glycated and Inflammatory Markers in Gestational Diabetes Mellitus

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