Clinical trial NCT05305352: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Gestational Diabetes
Inflammation
Metabolic Syndrome
Glucose Intolerance During Pregnancy
Glucose Intolerance
Insulin Resistance
Keywords: gestational diabetes
insulin resistance
carbohydrate
inflammation
glucose intolerance
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Asses change in Fasting blood glucose
timeFrame: Baseline after one month and two month
measure: Asses change in Postprandial glucose
timeFrame: Baseline after one month and two month
measure: Asses change in Glycated hemoglobin A1c (HbA1c)
timeFrame: Baseline after one month and two month
measure: Asses change in Lean and fat body mass
timeFrame: Baseline after one month and two month
measure: Asses change in Fasting insulin
timeFrame: Baseline after one month and two month
measure: Asses change in HOMA-IR
timeFrame: Baseline after one month and two month
measure: Asses change in Adiponectin
timeFrame: Baseline after one month and two month
measure: Carboxymethyl-lysine
timeFrame: Baseline after one month and two month
measure: Asses change in C-reactive protein
timeFrame: Baseline after one month and two month
measure: Asses change in NFk
timeFrame: Baseline after one month and two month
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Medical University
state: KPK
Study officials:
References:
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.
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.
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.
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.