Intervention of Artificial Intelligence in the Management of Nutritional Therapy Applied to Moroccan Type 2 Diabetics - Al-Khawarizmi Project
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Interstitial Glucose Levels
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental: Adapted Nutritional Intervention
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.
干预措施: Moroccan-Adapted Nutritional Plan (Behavioral)
结局指标
主要结局
Change in Interstitial Glucose Levels
时间窗: 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.
次要结局
- 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.)
研究者
Zineb Kabbaj
PhD student
Avicenna Military Hospital