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Gestational DiabetesNCT07336914

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

A study testing Dietary intervention + Physical Activity + Monitoring in people with Gestational Diabetes, run by Khyber Medical University Peshawar at 2 sites in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Gestational Diabetes
What is being tested?
Dietary intervention + Physical Activity + Monitoring
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesPakistan
Study dates
1 Oct 2025to 25 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Pakistan2 sites

  • Hayatabad Medical Complex

    Peshawar, Khyber Pakhtunkhwa, 25100

  • Northwest General Hospital

    Peshawar, Khyber Pakhtunkhwa, 25100

Other trials in Pakistan

About this study

Official title: Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes: Randomized Controlled Trial.

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.

Read the 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.

Being tested
Dietary intervention + Physical Activity + Monitoring, Usual care
Keywords
Gestational Diabetes Mellitus (GDM), Intensive Management, Randomized Controlled Trial (RCT), Glycemic Control, Maternal Health
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dietary intervention + Physical Activity + MonitoringCombination 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.

  • Usual careOther

    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.

Study groups in NCT07336914
Study groupRoleWhat they receive
Conventional Management GroupActive comparatorThis 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).
Receives: Other: Usual care
Intensive Management GroupExperimentalThis 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.
Receives: Combination Product: Dietary intervention + Physical Activity + Monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 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)

  1. Fasting or Random Blood Glucose Levels

    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.

    Measured: Baseline; Delivery; 6-12 weeks postpartum

  2. Serum Insulin Levels

    Insulin is measured using chemiluminescent immunoassay. A fasting insulin level >25 μIU/mL indicates hyperinsulinemia.

    Measured: 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.

  3. Serum CMPF

    Serum CMPF quantified using ELISA or mass spectrometry. Reported as a continuous variable; higher values indicate increased furan fatty acid levels.

    Measured: 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.

  4. Total Cholesterol

    Total cholesterol measured using enzymatic colorimetric assay; interpreted according to pregnancy-adjusted reference ranges.

    Measured: 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.

  5. LDL Cholesterol

    LDL measured directly or calculated using Friedewald formula; optimal levels <100 mg/dL.

    Measured: 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.

  6. HDL Cholesterol

    HDL analyzed using direct enzymatic methods; low HDL defined as <50 mg/dL in pregnancy.

    Measured: 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.

  7. Serum Creatinine

    Serum creatinine measured using Jaffe or enzymatic assay; pregnancy reference range 0.4-0.8 mg/dL.

    Measured: 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.

  8. Complete Blood Count (CBC)

    Includes hemoglobin, white blood cells, and platelet counts measured via automated hematology analyzer.

    Measured: 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.

  9. Amniotic Fluid Index (AFI)

    AFI measured using obstetric ultrasound; values <8 cm indicate oligohydramnios, >25 cm polyhydramnios.

    Measured: 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.

  10. Estimated Fetal Weight (EFW)

    EFW calculated using Hadlock fetal biometry formula; macrosomia defined as >4000 g.

    Measured: 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.

  11. Mode of Delivery

    Newborn weight measured using a calibrated digital scale. Low birth weight <2500 g; macrosomia >4000 g.

    Measured: Delivery (37-38 weeks)

  12. Neonatal Jaundice

    Defined as total serum bilirubin >5 mg/dL in the first 24 hours or above age-specific nomogram.

    Measured: Postpartum (42-45 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start1 Oct 2025
  3. Primary completion30 Mar 2026
  4. Study completion25 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of two groups (arms), and each group receives a different intervention concurrently.
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336914
Sponsor's protocol ID
KMU/DIR/CTU/2025/09
Status last verified
Jul 2026
First submitted
10 Dec 2025
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported in publications from this study will be made available to qualified researchers for legitimate scientific research.

Publications

  • 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.

    PubMed 20190296

  • 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.

    PubMed 34883186

  • 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.

    PubMed 24703697

  • 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.

    PubMed 38078583

  • 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.

    PubMed 27690122

  • 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.

    PubMed 15595297

Questions about this trial

What is this clinical trial studying?

A study testing Dietary intervention + Physical Activity + Monitoring in people with Gestational Diabetes, run by Khyber Medical University Peshawar at 2 sites in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c Levels (time frame: Baseline (24-28 weeks), Late Pregnancy/Delivery (37-38 weeks), Postpartum (42-45 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07336914, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.

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