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| Name | Class |
|---|---|
| Hopital La Rabta | OTHER |
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Ramadan, a fasting period observed by many Muslim patients, poses a significant challenge for glycemic management in diabetics. During this month, abstinence from food, water, and medication from dawn to dusk leads to significant glycemic fluctuations. Inadequate insulin dose management can cause acute complications such as hypoglycemia, hyperglycemia, ketosis, or hyperosmolar states. In 2021, the Diabetes and Ramadan (DAR) guidelines provided recommendations for adjusting insulin doses, taking into account changes in circadian rhythms and patients' dietary habits. However, these standardized recommendations may not be suitable for everyone. A personalized alternative, the Carbohydrate Fasting Test (CFT), allows for the assessment of individual basal insulin needs through a controlled fast excluding carbohydrates for 24 hours. Comparing these two approaches could provide valuable insights into their relative effectiveness, particularly in terms of safety and quality of life for patients.
Moreover, diabetes can be influenced by fasting, with potentially beneficial effects on inflammation and metabolism.
This study aims to determine which of these two methods optimizes glycemic control and to assess the variations of inflammation markers before and after Ramadan fasting. The results could be integrated into future clinical practices to improve diabetes management during Ramadan. We aim to compare the effectiveness and safety of basal insulin dose adjustments according to DAR 2021 guidelines versus the Carbohydrate Fasting Test (CFT) and to analyze the impact on the quality of life of diabetic patients. This is a prospective, longitudinal, randomized, interventional study including 60 Type 2 diabetic patients, aged 18 to 70 years old, on insulin therapy for at least 6 months. All participants intend to fast during Ramadan and are at low to moderate risk according to the IDF-DAR score (≤6).
Eligible patients will be randomly assigned into two groups:
DAR Group: Insulin dose adjustments according to DAR 2021 recommendations. CFT Group: Personalized insulin adjustments based on a Carbohydrate Fasting Test conducted before Ramadan.
Protocol:
Initial assessment will be Clinical ( Weight, BMI, blood pressure) and biological (Fasting glucose, HbA1c, fructosamine and inflammatory markers ( Interleukin 6 and TNF alfa)).
During Ramadan, weekly glycemic monitoring will be conducted to track blood sugar levels. Any complications will be recorded, and insulin dose adjustments will be made remotely if necessary to ensure optimal glycemic control.
In the last week of Ramadan, a final clinical assessment will be performed, including measurements of weight, BMI, and blood pressure. A biological assessment will also be conducted to measure fructosamine levels and inflammatory markers ( Interleukin 6 and TNF alfa).
Two months after Ramadan, fasting glucose and HbA1c levels will be re-evaluated to assess long-term glycemic control. The study will also analyze the impact on glycemic regulation, anthropometric parameters, and overall quality of life using the SF-12 questionnaire.
In conclusion, this project aims to identify the most effective method for adjusting basal insulin doses during Ramadan, contributing to optimal Type 2 diabetes management and to assess the variations of inflammation markers before and after Ramadan fasting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAR Group | Active Comparator | The basal insulin doses will be adjusted in accordance with the recommendations published by DAR in 2021 for diabetic patients during Ramadan. |
|
| CFT Group | Active Comparator | The basal insulin doses will be adjusted after a carbohydrate fasting test to assess individual insulin needs during fasting periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adjustment of insulin doses DAR | Drug | Patients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12), biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) DAR Group: Insulin will be adjusted per DAR 2021 guidelines. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support. During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control. |
| Measure | Description | Time Frame |
|---|---|---|
| fructosamine levels | Fructosamine variation 15 days before & the last week of Ramadan | up to 6 weeks |
| Interleukin-6 levels | variation during the fast of Ramadan 15 dayd before and at the Last week of Ramadan | up to 6 weeks |
| Hypoglycemia | Frequency of hypoglycemic episodes | up to one month |
| glycemic auto-monitoring | Percentage of blood glucose values meeting target levels during the month of Ramadan | up to one month |
| HbA1c levels | HbA1c variation before and after Ramadan 15 days before & 2 months after Ramadan | up to 6 weeks |
| TNF-alfa levels | Variation during fasting Ramadan 15 days before and at the Last week of Ramadan | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index | Body mass index variation : Before and at the Last week of Ramadan | up to 6 weeks |
| Quality of life of patients | Quality of life of patients assessed using the Medical Outcomes Study Short-Form General Health Survey (SF-12) questionnaire in its validated Tunisian dialect version. Before and at at the last week of Ramadan Higher score means a better quality of life. |
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Inclusion Criteria:
Non-Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Rabta Hospital , Endocrinology Department | Tunis | 1000 | Tunisia |
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| Adjustment of insulin doses CFT | Drug | Patients will be hospitalized at La Rabta Hospital from February 15 to February 28, 2025 for clinical (weight, BP, SF-12) and biological (HbA1c, lipid profile) assessments and inflammatory markers (Interleukin 6 and TNF alfa) . CFT Group: Insulin adjusted after a Carbohydrate Fasting Test. Patients will track insulin doses, glycemic cycles, hypoglycemia episodes, fasting interruptions, and hospital visits in a dedicated log. They will receive weekly calls for insulin adjustments and continuous support. During the last week of Ramadan, clinical and biological data including inflammatory markers will be collected. Two months post-Ramadan, HbA1c, fasting glucose, and lipid profile will be reassessed to evaluate glycemic control. |
|
| up to 6 weeks |
| waist circumference | variation of waist circumference: Before and at the Last week of Ramadan | up to 6 weeks |
| Blood pressure | Variation of blood pressure : Before and at the Last week of Ramadan | up to 6 weeks |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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