Reflexo Therapy for Gestational Diabetes Mellitus

Not Applicable

Recruiting

• Conditions: Physical Therapy

• Registration Number: NCT06976164
• Lead Sponsor: Kafrelsheikh University

Brief Summary

The purpose of this study will be to detect the effects of Reflexo therapy of sole on GDM.

Detailed Description

Gestational diabetes mellitus is considered a hazard factor for antenatal complications for both mother and fetus. It is characterized by glucose intolerance of variable degrees with the beginning or first recognition of pregnancy. It affects 14% of pregnancies worldwide, and it undergoes continuous changes in the diagnostic criteria, ethnicity and the population studied.

There is an increasing prevalence of diabetes mellitus, and its major metabolic disorder caused by the insulin secretion defect or insulin action defect resulting from a defect in insulin secretion, insulin action, or both. As a result, it will lead to chronic hyperglycemia associated with carbohydrates, protein, and fat disturbance.

In spite of the fact that the reason for gestational diabetes mellitus is still not fully understood, it is proposed that human placental lactogen has growth hormone-like actions, and that it causes lipolysis and thus increases the levels of circulating fatty acids that repress the action of insulin and cause insulin resistance in pregnant females which appear to play a crucial role in the pathogenesis of gestational diabetes mellitus.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-01
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-08
• Last Update Submitted: 2025-05-08
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

1. They were maternally aged between 20 and 35 years.
2. The gestational age ranged from between 24 and 36 weeks.
3. Their BMI didn't exceed 30 kg/m2.
4. A singleton live fetus and not under stressful event.

Exclusion Criteria

1. They had high-risk pregnancies.
2. Bad obstetric situations.
3. Diseases that could interfere with participation.
4. Smoking.
5. Oral sedative administration.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in The Oral Glucose Tolerance Test.	Change from Baseline Oral Glucose Tolerance Test at one month
Change in The Hemoglobin A1C Test.	Change from Baseline Hemoglobin A1C Test at one month

Trial Locations

Locations (1)

The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University.; 🇪🇬 Cairo, Egypt