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

NCT07336914 | Recruiting DMC

• 1 other identifier: KMU/DIR/CTU/2025/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes Mellitus (GDM); Intensive Management; Randomized Controlled Trial (RCT); Glycemic Control; Maternal Health

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c Levels

  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.

  Baseline (24-28 weeks), Late Pregnancy/Delivery (37-38 weeks), Postpartum (42-45 weeks)

• Physical Activity Level (PAQ)

  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.

  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)

Secondary Outcomes (12)

• Fasting or Random Blood Glucose Levels

  Baseline; Delivery; 6-12 weeks postpartum

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Conventional Management Group

ACTIVE COMPARATOR

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).

Other: Usual care

Intensive Management Group

EXPERIMENTAL

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.

Combination Product: Dietary intervention + Physical Activity + Monitoring

Interventions

Dietary intervention + Physical Activity + Monitoring 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.

Intensive Management Group

Usual care 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.

Conventional Management Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Maternal age between 18-45 years
• Gestational age at enrollment 24 - 28 weeks
• Patients having Hba1c levels less then 6%

You may not qualify if:

• 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

Sponsors & Collaborators

• Hayatabad Medical Complex: collaborator
• Khyber Medical University Peshawar: lead
• Northwest General Hospital and Research centre: collaborator

Study Sites (2)

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

NOT YET RECRUITING

Northwest General Hospital

Peshawar, Khyber Pakhtunkhwa, 25100, Pakistan

RECRUITING

Related Publications (6)

• 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.

  PMID: 20190296 BACKGROUND

• 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.

  PMID: 34883186 BACKGROUND

• 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.

  PMID: 24703697 BACKGROUND

• 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.

  PMID: 38078583 BACKGROUND

• 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.

  PMID: 27690122 BACKGROUND

• 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.

  PMID: 15595297 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Diet Therapy; Exercise

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr Kausar Tayyab, PhD*

  Institute of Basic Medical Sciences, Khyber Medical University

  PRINCIPAL INVESTIGATOR

• Dr Rubina Nazli, PhD

  Institute of Basic Medical Sciences, Khyber Medical University

  PRINCIPAL INVESTIGATOR

• Dr Arshad Hussain, PhD

  Northwest General Hospital, Peshawar

  PRINCIPAL INVESTIGATOR

• Dr Ehtesham, PhD

  Institute of Basic Medical Sciences, Khyber Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Kausar Tayyab, PhD*

CONTACT

+923338645454; kausar.tayyab1234@gmail.com

Dr Rubina Nazli, PhD

CONTACT

+923215773696; rubinanazli44@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The nature of the interventions (monthly vs. weekly follow-up, different monitoring intensities) makes blinding of participants and care providers impossible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two groups (arms), and each group receives a different intervention concurrently.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 13, 2026
• Study Start: October 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: April 25, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available 12 months after the publication of the primary results and will remain accessible for at least 5 years.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal approved by the study's principal investigator and the Institutional Review Board (IRB) of Khyber Medical University. Proposals should be directed to the corresponding author. Data will be shared via a secure, password-protected platform after signing a data use agreement.

Locations

PA (2)