Effect of Very Low Carbohydrate Diet on Glycemic, Metabolic, Glycated and Inflammatory Markers in Gestational Diabetes Mellitus
NCT ID: NCT05305352
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2025-01-31
2025-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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No intervention
The no intervention arm will not receive counselling but will follow their routine diet suggested during their routine antenatal visits.
No interventions assigned to this group
Intervention
The intervention arm will be counselled about very low carbohydrate diet (\<10%carbohydrate)
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Either taking or not taking oral hypoglycemic agent or insulin
Exclusion Criteria
* Age less than 18 and above 40 years
* Any other chronic disease
18 Years
40 Years
FEMALE
No
Sponsors
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Khyber Medical University Peshawar
OTHER
Responsible Party
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Bibi Hajira
Assistant Professor
Locations
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Khyber Medical University
Peshawar, KPK, Pakistan
Countries
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References
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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.
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.
Other Identifiers
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DIR/KMU-AS&RB/EV/001551
Identifier Type: -
Identifier Source: org_study_id
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