Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
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:
Data collection and Scientific tools:
The study utilizes high-precision monitoring tools to ensure data reliability:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Adapted Nutritional Intervention | Experimental | A single group of 50 Type 2 Diabetic patients will participate in a four-stage intervention over 180 days.
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moroccan-Adapted Nutritional Plan | Behavioral | The intervention consists of a structured diet plan that integrates traditional Moroccan ingredients and cooking methods while optimizing for glycemic control. It involves:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Measurement of glycated hemoglobin to assess long-term glycemic control through laboratory samples. | Baseline (Day 0) and Day 180. |
| Change in Body Mass Index (BMI) | Calculation of BMI based on weight and height measurements. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hicham Baïzri | Department of Endocrinology, Diabetology and Metabolic Diseases, Avicenne Military Hospital, Marrakech, Morocco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avicenna Military Hospital of Marrakech | Marrakesh | Marrakesh-Safi | 40160 | Morocco |
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.
Data will be available beginning 6 months after publication of the results and ending 3 years after publication.
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.
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline (Day 0) and Day 180. |
| Change in Waist Circumference | Anthropometric measurement of the waist to evaluate changes in abdominal adiposity. | Baseline (Day 0) and Day 180. |
| Change in Body Composition | Assessment of body fat and lean mass using bioelectrical impedance. | 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. | Baseline (Day 7) compared to Day 180. |
| D004700 | Endocrine System Diseases |