Impact of Therapeutic Education for Type 2 Diabetic Patients During Ramadan.

NCT ID: NCT07112625

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-10

Study Completion Date

2019-06-15

Brief Summary

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This randomized controlled trial evaluates the impact of therapeutic education, with or without personalized coaching, on clinical and biological outcomes in patients with type 2 diabetes during Ramadan fasting. Participants were randomly assigned to three groups: Control (usual care), Education Only, and Education plus Coaching. All received a 30-minute pre-Ramadan education session; the Education plus Coaching group also had follow-up telephone consultations. Outcomes included HbA1c, fasting blood glucose, cholesterol, BMI, and blood pressure measured before and after Ramadan. The study aims to assess whether structured education and ongoing coaching help patients fast safely and maintain better metabolic control.

Detailed Description

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Conditions

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Diabete Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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education and coaching

education before ramadan fasting and during ramadan

Group Type ACTIVE_COMPARATOR

education and coaching

Intervention Type OTHER

education associated to coaching

education only

education before ramadan fasting only

Group Type ACTIVE_COMPARATOR

education

Intervention Type OTHER

education without coaching

Controle

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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education and coaching

education associated to coaching

Intervention Type OTHER

education

education without coaching

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Type 2 diabetic patients taking oral treatment who intended to fast during Ramadan and agreed to participate in the study.

Exclusion Criteria

* Patients with severe comorbidities (renal failure, recent coronary disease, cognitive impairement) and those classified as very high risk for fasting
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Monastir

OTHER

Sponsor Role lead

Responsible Party

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Imen Zemni

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Semir Nouira, Medical Doctor

Role: STUDY_CHAIR

Fattouma bourguiba university hospital of Monastir

Locations

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Fattouma Bourguiba University Hospital

Monastir, , Tunisia

Site Status

Countries

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Tunisia

Other Identifiers

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UMONASTIR2

Identifier Type: -

Identifier Source: org_study_id

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