Gestational Diabetes
Conditions
Keywords
Gestational Diabetes Mellitus (GDM), Intensive Management, Randomized Controlled Trial (RCT), Glycemic Control, Maternal Health
Brief summary
This study involved two management protocols to manage diabetes in pregnancy. Sixty patients having GDM will be recruited on the basis of the OGTT and randomly allocated to two management groups. One group of patients will receive counselling and the conventional method of management. while the other group will receive a tailored diet plan and physical activity with low caloric and moderate intense exercises. Both groups will receive a dietary plan based on their sugar levels weekly basis and physical activity with pharmacotherapy to adjust their sugar levels, while the intensive group will have rigorous monitoring on a monthly basis and frequent visits with repeated lab checks. This will help us to reduce short and long-term complications with improved maternal and neonatal outcomes.
Detailed description
This randomized controlled trial aims to compare the efficacy of conventional versus intensive management strategies for Gestational Diabetes Mellitus (GDM) and their impact on maternal and fetal outcomes. The study will enrol 60 pregnant women diagnosed with GDM at 24-28 weeks of gestation. Participants will be randomly assigned to either a conventional group, which receives standard monthly follow-up and counselling, or an intensive group, which receives proactive weekly monitoring, personalised diet and exercise plans, and stricter glycemic targets. The primary outcomes include differences in glycemic control (glucose, HbA1c), levels of the biomarker CMPF, and the incidence of maternal and neonatal complications. Data will be collected throughout pregnancy and postpartum, and analyzed using statistical methods in SPSS to determine the superior management approach for improving health outcomes in GDM.
Interventions
COMBINATION_PRODUCTDietary intervention + Physical Activity + Monitoring
Dietary modifications will follow an 1800-kilocalorie structured plan that includes breakfast, two snacks, lunch, and dinner. The plan will focus on low carbohydrate intake with restrictions on lean options. Adherence will be closely monitored, with a monthly adherence questionnaire (PDAQ) to ensure tight blood sugar control. In terms of physical activity, a structured exercise plan will incorporate household activities, occupational tasks, and various levels of exercise, ranging from light to moderate and intense. Strict monitoring and follow-up will be conducted monthly using the Physical Activity Adherence Questionnaire (PAAQ). Secondly, short acting and long acting insulin dose and frquency will be monitored.
OTHERUsual care
General advice and recommendations for a low glycemic diet include a flexible and adjusted daily calorie intake, structured meals without a fixed menu. Patients should be educated about healthy choices and empowered to manage their own health. Exercise recommendations should be tailored to the participant's activity level, with routine ANC counseling and no standard follow-up process. If lifestyle modifications are ineffective in controlling glycemic levels, glucophage and human insulin R will be prescribed.
Sponsors
Khyber Medical University Peshawar
Northwest General Hospital and Research centre
Hayatabad Medical Complex
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The nature of the interventions (monthly vs. weekly follow-up, different monitoring intensities) makes blinding of participants and care providers impossible.
Intervention model description
Participants are randomly assigned to one of two groups (arms), and each group receives a different intervention concurrently.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Maternal age between 18-45 years * Gestational age at enrollment 24 - 28 weeks * Patients having Hba1c levels less then 6%
Exclusion criteria
* Patients having twin pregnancies * Patients having PCOS * Diabetes diagnosed prior to pregnancy * Patients having severe hypertension * Patients having renal diseases * Patients using glucose altering medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c Levels | Baseline (24-28 weeks), Late Pregnancy/Delivery (37-38 weeks), Postpartum (42-45 weeks) | HbA1c is measured using high-performance liquid chromatography (HPLC). Values will be compared from baseline to delivery/late pregnancy and postpartum to assess improvement or deterioration in glycemic control. |
| Physical Activity Level (PAQ) | Conventional Management: Baseline, Delivery (37-38 weeks), Postpartum (42-45 weeks) Intensive Management: Baseline, 2nd Visit (32-34 weeks), 3rd Visit (36-38 weeks), 4th Visit (40-42 weeks), Postpartum (42-45 weeks) | Physical activity is assessed using the Physical Activity Questionnaire (PAQ), an ordinal scale ranging from 1 to 5. A score ≤2 indicates sedentary activity, while a score ≥3 indicates active physical activity levels. Higher scores reflect greater physical activity engagement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting or Random Blood Glucose Levels | Baseline; Delivery; 6-12 weeks postpartum | Blood glucose is measured using the enzymatic glucose oxidase method. A fasting value ≥92 mg/dL is considered abnormal, and a random value ≥200 mg/dL suggests hyperglycemia. |
| Serum Insulin Levels | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | Insulin is measured using chemiluminescent immunoassay. A fasting insulin level \>25 μIU/mL indicates hyperinsulinemia. |
| Serum CMPF | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | Serum CMPF quantified using ELISA or mass spectrometry. Reported as a continuous variable; higher values indicate increased furan fatty acid levels. |
| Total Cholesterol | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | Total cholesterol measured using enzymatic colorimetric assay; interpreted according to pregnancy-adjusted reference ranges. |
| LDL Cholesterol | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | LDL measured directly or calculated using Friedewald formula; optimal levels \<100 mg/dL. |
| HDL Cholesterol | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | HDL analyzed using direct enzymatic methods; low HDL defined as \<50 mg/dL in pregnancy. |
| Serum Creatinine | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | Serum creatinine measured using Jaffe or enzymatic assay; pregnancy reference range 0.4-0.8 mg/dL. |
| Complete Blood Count (CBC) | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | Includes hemoglobin, white blood cells, and platelet counts measured via automated hematology analyzer. |
| Amniotic Fluid Index (AFI) | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | AFI measured using obstetric ultrasound; values \<8 cm indicate oligohydramnios, \>25 cm polyhydramnios. |
| Estimated Fetal Weight (EFW) | Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum. | EFW calculated using Hadlock fetal biometry formula; macrosomia defined as \>4000 g. |
| Mode of Delivery | Delivery (37-38 weeks) | Newborn weight measured using a calibrated digital scale. Low birth weight \<2500 g; macrosomia \>4000 g. |
| Neonatal Jaundice | Postpartum (42-45 days) | Defined as total serum bilirubin \>5 mg/dL in the first 24 hours or above age-specific nomogram. |
Countries
Pakistan
Contacts
PRINCIPAL_INVESTIGATORDr Kausar Tayyab, PhD*
Institute of Basic Medical Sciences, Khyber Medical University
PRINCIPAL_INVESTIGATORDr Rubina Nazli, PhD
Institute of Basic Medical Sciences, Khyber Medical University
PRINCIPAL_INVESTIGATORDr Arshad Hussain, PhD
Northwest General Hospital, Peshawar
PRINCIPAL_INVESTIGATORDr Ehtesham, PhD
Institute of Basic Medical Sciences, Khyber Medical University
Outcome results
None listed