- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07404280
Impact of a Nutritional Intervention Based on Moroccan Dietary Habits on the Glycemic Control of Type 2 Diabetics
Intervention of Artificial Intelligence in the Management of Nutritional Therapy Applied to Moroccan Type 2 Diabetics - Al-Khawarizmi Project
The goal of this study is to learn if a nutritional intervention adapted to Moroccan dietary habits can improve blood sugar control in adults with Type 2 Diabetes. The main questions it aims to answer are:
- Does a personalized diet based on Moroccan culinary traditions improve long-term blood sugar levels (HbA1c)?
- How does this intervention affect daily blood sugar fluctuations measured as interstitial glucose?
- Does the intervention lead to changes in body measurements, such as weight and Body Mass Index (BMI)?
Participants will:
- Wear a Continuous Glucose Monitor (CGM) to track sugar levels in real-time.
- Keep a detailed food diary of all foods and drinks consumed.
- Follow their usual diet for the first 7 days to establish a baseline.
- Receive personalized dietary advice specifically tailored to Moroccan food habits.
- Return for clinical check-ups at 14, 90, and 180 days for blood tests and body measurements.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study follows a quasi-experimental, before-after design conducted in a clinical setting. The research is structured to evaluate the metabolic and anthropometric response of Type 2 Diabetic (T2D) patients to a culturally tailored nutritional intervention. The trial is longitudinal, spanning a total duration of 180 days per participant.
Intervention Phases:
The protocol is divided into distinct chronological stages to capture both baseline data and intervention outcomes:
- Baseline Phase (Days 1-7): Participants maintain their habitual "free" diet to establish a baseline for glycemic variability and caloric intake. During this phase, Continuous Glucose Monitoring (CGM) systems and detailed food diaries are used to map postprandial glucose responses to traditional Moroccan meals.
- Intervention Initiation (Day 7- T7): A specialized dietitian analyzes the baseline food diaries and CGM cycles to provide personalized nutritional directives. These directives adapt international dietary standards to the specific ingredients, cooking methods, and flavor profiles of Moroccan cuisine.
- Adjustment and Stabilization (Day 14- T14): A follow-up consultation is held to assess initial adherence and refine the nutritional recommendations based on the participant's feedback and early glycemic data.
- Medium and Long-term Follow-up (T90 & T180): Metabolic stability is evaluated at 3 and 6 months. These stages involve comprehensive biological testing and anthropometric measurements to determine the sustainability of the intervention's effects.
Data collection and Scientific tools:
The study utilizes high-precision monitoring tools to ensure data reliability:
- Continuous Glucose Monitoring (CGM): Sensors are used to record interstitial glucose levels in real-time, providing a more granular view of glycemic control that traditional finger-stick testing.
- Nutritional Analysis: Food intake is quantified through structured diaries, kitchen scales for portion control, and validated food frequency questionnaires.
- Anthropometric and metabolic Markers: Bioelectrical impedance analysis (BIA) is used to track body composition changes, while laboratory tests measure HbA1c, fasting blood glucose, and lipid and renal profiles.
Statistical Analysis Plan Data will be analyzed using a within-subject comparison. Descriptive statistics will summarize baseline characteristics. Paired t-tests and ANOVA will be employed to compare glycemic and anthropometric variables across the four time points (T0, T7, T90, T180), with a significance level set to p<0.05. Additionally, Pearson or Spearman correlation tests and Artificial Intelligence techniques will examine the association between specific Moroccan dietary patterns and glycemic fluctuations.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Marrakech Safi
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Marrakesh, Marrakech Safi, Morocco, 40160
- Avicenna Military Hospital of Marrakech
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed diagnosis of T2D by a healthcare professional.
- Age 18 years or older.
- A glycated hemoglobin (HbA1c) level less than 10%.
- Capacity to provide informed written consent and follow the study procedures.
Exclusion Criteria:
- Non-diabetic subjects.
- Type 1 diabetes or secondary diabetes.
- Age younger than 18 years.
- Pregnancy or planned pregnancy during the study period.
- HbA1c level greater than 10%.
- Chronic renal insufficiency or hepatic disease.
- Pathologies of the digestive tract that affect nutrient absorption.
- Known food allergies requiring highly specific restricted diets.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Adapted Nutritional Intervention
A single group of 50 Type 2 Diabetic patients will participate in a four-stage intervention over 180 days.
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The intervention consists of a structured diet plan that integrates traditional Moroccan ingredients and cooking methods while optimizing for glycemic control. It involves:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Interstitial Glucose Levels
Time Frame: Baseline (Day 0 to Day 7) compared to the final follow-up at Day 180.
|
Evaluation of the impact of the Moroccan-adapted nutritional intervention on daily glucose fluctuations.
This is measured using a Continuous Glucose Monitoring (CGM) system to record real-time glucose data.
|
Baseline (Day 0 to Day 7) compared to the final follow-up at Day 180.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in HbA1c
Time Frame: Baseline (Day 0) and Day 180.
|
Measurement of glycated hemoglobin to assess long-term glycemic control through laboratory samples.
|
Baseline (Day 0) and Day 180.
|
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Change in Body Mass Index (BMI)
Time Frame: Baseline (Day 0) and Day 180.
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Calculation of BMI based on weight and height measurements.
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Baseline (Day 0) and Day 180.
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Change in Body Composition
Time Frame: Baseline (Day 0) and Day 180.
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Assessment of body fat and lean mass using bioelectrical impedance.
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Baseline (Day 0) and Day 180.
|
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Dietary Adherence
Time Frame: Baseline (Day 7) compared to Day 180.
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Evaluation of changes in dietary habits and adherence to the personalized Moroccan-adapted recommendations using food diaries.
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Baseline (Day 7) compared to Day 180.
|
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Change in Waist Circumference
Time Frame: Baseline (Day 0) and Day 180.
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Anthropometric measurement of the waist to evaluate changes in abdominal adiposity.
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Baseline (Day 0) and Day 180.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hicham Baïzri, Department of Endocrinology, Diabetology and Metabolic Diseases, Avicenne Military Hospital, Marrakech, Morocco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 153/2024/2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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