NCT07404280

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Oct 2024Sep 2026

Study Start

First participant enrolled

October 1, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

February 5, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Type 2 DiabetesArtificial IntelligenceNutritional InterventionGlycemic ControlMoroccan Dietary HabitsPrecision Nutrition

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline (Day 0 to Day 7) compared to the final follow-up at Day 180.

Secondary Outcomes (5)

  • Change in HbA1c

    Baseline (Day 0) and Day 180.

  • Change in Body Mass Index (BMI)

    Baseline (Day 0) and Day 180.

  • Change in Waist Circumference

    Baseline (Day 0) and Day 180.

  • Change in Body Composition

    Baseline (Day 0) and Day 180.

  • Dietary Adherence

    Baseline (Day 7) compared to Day 180.

Study Arms (1)

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.

Behavioral: Moroccan-Adapted Nutritional Plan

Interventions

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.

Experimental: Adapted Nutritional Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avicenna Military Hospital of Marrakech

Marrakesh, Marrakech Safi, 40160, Morocco

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hicham Baïzri

    Department of Endocrinology, Diabetology and Metabolic Diseases, Avicenne Military Hospital, Marrakech, Morocco

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 11, 2026

Study Start

October 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be available beginning 6 months after publication of the results and ending 3 years after publication.
Access Criteria
Data will be shared with researchers who provide a methodologically sound proposal and after signing a data access agreement to ensure ethical use and patient anonymity.

Locations