Effect of Very Low Carbohydrate Diet on Glycemic, Metabolic, Glycated and Inflammatory Markers in Gestational Diabetes Mellitus
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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).
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
2nd trimester women with GDM
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Either taking or not taking oral hypoglycemic agent or insulin
Exclusion Criteria:
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Previously known type 1 or type 2 Diabetic patients
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Age less than 18 and above 40 years
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Any other chronic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Khyber Medical University | Peshawar | KPK | Pakistan | 25100 |
Sponsors and Collaborators
- Khyber Medical University Peshawar
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
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.
- 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, López-Pedrosa JM, Campoy C, Rueda R. The Role of Dietary Carbohydrates in Gestational Diabetes. Nutrients. 2020 Jan 31;12(2). pii: E385. doi: 10.3390/nu12020385. Review.
- 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.
- DIR/KMU-AS&RB/EV/001551