Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes

NCT ID: NCT07336914

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-04-25

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.

Conditions

Gestational Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Management Group

This group receives standard care for conventional management of GDM identified via survey in government and private sectors. This includes monthly follow-up visits with basic lifestyle modification and counselling on dietary and physical acitivity assessed via questionnaires (PDAQ and PPAQ). Medication (insulin or oral agents like metformin) is only introduced if glycemic targets are not achieved through lifestyle modifications alone. Blood glucose monitoring is performed at a standard frequency (e.g., pre- and post-meal).

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: OTHER

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.

Intensive Management Group

This group receives a standardized, intensive multidisciplinary intervention. It includes weekly telephonic monitoring, personalized low-carbohydrate/calorie diet plans, and structured moderate and intense exercise based on their activty level. Pharmacotherapy (insulin, metformin, etc.) is initiated proactively if glucose levels are not controlled within two weeks. Enhanced fetal monitoring via frequent ultrasounds is also included to assess growth and amniotic fluid. This management involves frequent antenatal visits with pre- and post-sugar monitoring for dietary and physical therapy. Secondly, rigorous monitoring will be done using Ultrasound and repeated lab tests via a dietary and physical monthly recall questionnaire.

Group Type: EXPERIMENTAL

Dietary intervention + Physical Activity + Monitoring

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

Dietary 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.

Intervention Type: COMBINATION_PRODUCT

Usual 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwest General Hospital and Research centre

NETWORK

Sponsor Role: collaborator

Hayatabad Medical Complex

OTHER_GOV

Sponsor Role: collaborator

Khyber Medical University Peshawar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Kausar Tayyab, PhD*

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Medical Sciences, Khyber Medical University

Dr Rubina Nazli, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Medical Sciences, Khyber Medical University

Dr Arshad Hussain, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwest General Hospital, Peshawar

Dr Ehtesham, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Basic Medical Sciences, Khyber Medical University

Locations

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status: NOT_YET_RECRUITING

Northwest General Hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Dr Kausar Tayyab, PhD*

Role: CONTACT

kausar.tayyab1234@gmail.com

+923338645454

Dr Rubina Nazli, PhD

Role: CONTACT

rubinanazli44@gmail.com

+923215773696

Facility Contacts

Dr Rubina Akhtar, FCPS Gyne

Role: primary

rubiktk@hotmail.com

03009339930

Dr Rukhsana Kareem

Role: backup

rukhsanakareem@mtihmc.edu.pk

03319278486

Dr Kausar Tayyab, PhD Scholar

Role: primary

kausar.tayyab1234@gmail.com

0333864545

Dr Arshad Hussian, PhD

Role: backup

Hussainadr@gmail.com

03312710692

References

International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.

Reference Type: BACKGROUND

PMID: 20190296 (View on PubMed)

Wang H, Li N, Chivese T, Werfalli M, Sun H, Yuen L, Hoegfeldt CA, Elise Powe C, Immanuel J, Karuranga S, Divakar H, Levitt N, Li C, Simmons D, Yang X; IDF Diabetes Atlas Committee Hyperglycaemia in Pregnancy Special Interest Group. IDF Diabetes Atlas: Estimation of Global and Regional Gestational Diabetes Mellitus Prevalence for 2021 by International Association of Diabetes in Pregnancy Study Group's Criteria. Diabetes Res Clin Pract. 2022 Jan;183:109050. doi: 10.1016/j.diabres.2021.109050. Epub 2021 Dec 6.

Reference Type: BACKGROUND

PMID: 34883186 (View on PubMed)

Prentice KJ, Luu L, Allister EM, Liu Y, Jun LS, Sloop KW, Hardy AB, Wei L, Jia W, Fantus IG, Sweet DH, Sweeney G, Retnakaran R, Dai FF, Wheeler MB. The furan fatty acid metabolite CMPF is elevated in diabetes and induces beta cell dysfunction. Cell Metab. 2014 Apr 1;19(4):653-66. doi: 10.1016/j.cmet.2014.03.008.

Reference Type: BACKGROUND

PMID: 24703697 (View on PubMed)

American Diabetes Association Professional Practice Committee. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S282-S294. doi: 10.2337/dc24-S015.

Reference Type: BACKGROUND

PMID: 38078583 (View on PubMed)

Asaad G, Soria-Contreras DC, Bell RC, Chan CB. Effectiveness of a Lifestyle Intervention in Patients with Type 2 Diabetes: The Physical Activity and Nutrition for Diabetes in Alberta (PANDA) Trial. Healthcare (Basel). 2016 Sep 27;4(4):73. doi: 10.3390/healthcare4040073.

Reference Type: BACKGROUND

PMID: 27690122 (View on PubMed)

Chasan-Taber L, Schmidt MD, Roberts DE, Hosmer D, Markenson G, Freedson PS. Development and validation of a Pregnancy Physical Activity Questionnaire. Med Sci Sports Exerc. 2004 Oct;36(10):1750-60. doi: 10.1249/01.mss.0000142303.49306.0d.

Reference Type: BACKGROUND

PMID: 15595297 (View on PubMed)

Other Identifiers

KMU/DIR/CTU/2025/09

Identifier Type: -

Identifier Source: org_study_id