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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05305352
Other study ID # DIR/KMU-AS&RB/EV/001551
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 2024
Est. completion date July 2024

Study information

Verified date May 2024
Source Khyber Medical University Peshawar
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Intervention

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).

Locations

Country Name City State
Pakistan Khyber Medical University Peshawar KPK

Sponsors (1)

Lead Sponsor Collaborator
Khyber Medical University Peshawar

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Asses change in Fasting blood glucose Baseline after one month and two month
Primary Asses change in Postprandial glucose Baseline after one month and two month
Primary Asses change in Glycated hemoglobin A1c (HbA1c) Baseline after one month and two month
Primary Asses change in Lean and fat body mass Baseline after one month and two month
Primary Asses change in Fasting insulin Baseline after one month and two month
Primary Asses change in HOMA-IR Baseline after one month and two month
Primary Asses change in Adiponectin Baseline after one month and two month
Primary Carboxymethyl-lysine Baseline after one month and two month
Primary Asses change in C-reactive protein Baseline after one month and two month
Primary Asses change in NFk Baseline after one month and two month
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