Type 2 Diabetes (T2DM)NCT07404280
Impact of a Nutritional Intervention Based on Moroccan Dietary Habits on the Glycemic Control of Type 2 Diabetics
A study testing Moroccan-Adapted Nutritional Plan in people with Type 2 Diabetes (T2DM), run by Avicenna Military Hospital at 1 site in Morocco.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- Moroccan-Adapted Nutritional Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteMorocco
- Study dates
- 1 Oct 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Morocco1 site
Avicenna Military Hospital of Marrakech
Marrakesh, Marrakesh-Safi, 40160
About this study
Official title: 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)?
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes (T2DM)
- Being tested
- Moroccan-Adapted Nutritional Plan
- Keywords
- Type 2 Diabetes, Artificial Intelligence, Nutritional Intervention, Glycemic Control, Moroccan Dietary Habits, Precision Nutrition
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moroccan-Adapted Nutritional PlanBehavioural
The intervention consists of a structured diet plan that integrates traditional Moroccan ingredients and cooking methods while optimizing for glycemic control. It involves:
- Personalized meal planning based on individual food diaries.
- Education on carbohydrate counting and portion sizes within the Moroccan culinary context.
- Use of Continuous Glucose Monitoring (CGM) data to provide real-time feedback on how specific Moroccan meals affect the participant's glucose levels.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Adapted Nutritional Intervention | Experimental | A single group of 50 Type 2 Diabetic patients will participate in a four-stage intervention over 180 days.
* Phase 1 (Baseline): Participants will follow their usual, free diet for 7 days while monitored by Continuous Glucose Monitoring (CGM) and food diaries to establish a baseline.
* Phase 2 (Intervention): Participants receive personalized nutritional directives specifically adapted to traditional Moroccan dietary habits and culinary practices.
* Phase 3 (Follow-up): Continuous monitoring and periodic consultations (at Day 14, Day 90, and Day 180) to adjust the intervention, measure metabolic changes (HbA1c), and evaluate anthropometric parameters. Receives: Behavioral: Moroccan-Adapted Nutritional Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interstitial Glucose Levels
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.
Measured: Baseline (Day 0 to Day 7) compared to the final follow-up at Day 180.
Secondary outcomes (5)
Change in HbA1c
Measurement of glycated hemoglobin to assess long-term glycemic control through laboratory samples.
Measured: Baseline (Day 0) and Day 180.
Change in Body Mass Index (BMI)
Calculation of BMI based on weight and height measurements.
Measured: Baseline (Day 0) and Day 180.
Change in Waist Circumference
Anthropometric measurement of the waist to evaluate changes in abdominal adiposity.
Measured: Baseline (Day 0) and Day 180.
Change in Body Composition
Assessment of body fat and lean mass using bioelectrical impedance.
Measured: Baseline (Day 0) and Day 180.
Dietary Adherence
Evaluation of changes in dietary habits and adherence to the personalized Moroccan-adapted recommendations using food diaries.
Measured: Baseline (Day 7) compared to Day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Oct 2024
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avicenna Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zineb Kabbaj, Avicenna Military Hospital
- Investigators
- Hicham Baïzri, Study director, Department of Endocrinology, Diabetology and Metabolic Diseases, Avicenne Military Hospital, Marrakech, Morocco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404280
- Sponsor's protocol ID
- 153/2024/2026
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study and the final article (text, tables, figures, and appendices), after de-identification, will be made available to researchers who provide a methodologically sound proposal. Request should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention of Artificial Intelligence in the Management of Nutritional Therapy Applied to Moroccan Type 2 Diabetics - Al-Khawarizmi Project
- ClinicalTrials.gov ID
- NCT07404280
- Acronym / sponsor ID
- 153/2024/2026
- Conditions
- Type 2 Diabetes (T2DM)
- Keywords
- Type 2 Diabetes, Artificial Intelligence, Nutritional Intervention, Glycemic Control, Moroccan Dietary Habits, Precision Nutrition
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Avicenna Military HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Adapted Nutritional Intervention | Experimental | Behavioral: Moroccan-Adapted Nutritional PlanA single group of 50 Type 2 Diabetic patients will participate in a four-stage intervention over 180 days. * Phase 1 (Baseline): Participants will follow their usual, free diet for 7 days while monitored by Continuous Glucose Monitoring (CGM) and food diaries to establish a baseline. * Phase 2 (Intervention): Participants receive personalized nutritional directives specifically adapted to traditional Moroccan dietary habits and culinary practices. * Phase 3 (Follow-up): Continuous monitoring and periodic consultations (at Day 14, Day 90, and Day 180) to adjust the intervention, measure metabolic changes (HbA1c), and evaluate anthropometric parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moroccan-Adapted Nutritional PlanThe intervention consists of a structured diet plan that integrates traditional Moroccan ingredients and cooking methods while optimizing for glycemic control. It involves: * Personalized meal planning based on individual food diaries. * Education on carbohydrate counting and portion sizes within the Moroccan culinary context. * Use of Continuous Glucose Monitoring (CGM) data to provide real-time feedback on how specific Moroccan meals affect the participant's glucose levels. | Behavioural | Experimental: Adapted Nutritional Intervention |
Primary outcome
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.
5 secondary outcomes
Change in HbA1c
Time frame: Baseline (Day 0) and Day 180.
Change in Body Mass Index (BMI)
Time frame: Baseline (Day 0) and Day 180.
Change in Waist Circumference
Time frame: Baseline (Day 0) and Day 180.
Change in Body Composition
Time frame: Baseline (Day 0) and Day 180.
Dietary Adherence
Time frame: Baseline (Day 7) compared to Day 180.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study and the final article (text, tables, figures, and appendices), after de-identification, will be made available to researchers who provide a methodologically sound proposal. Request should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicham Baïzri study director
Department of Endocrinology, Diabetology and Metabolic Diseases, Avicenne Military Hospital, Marrakech, Morocco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moroccan-Adapted Nutritional Plan in people with Type 2 Diabetes (T2DM), run by Avicenna Military Hospital at 1 site in Morocco.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. 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?
This study is still under way. Results are not available in the source record yet.
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 Interstitial Glucose Levels (time frame: Baseline (Day 0 to Day 7) compared to the final follow-up at Day 180.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.