Clinical trial NCT06826547: Optimization of Basal Insulin During Ramadan Fasting in Type 2 Diabetic Patients: Comparison Between DAR Recommendations and the Carbohydrate Fasting Test & Metabolic and Inflammatory Consequences
Official title: Optimization of Basal Insulin During Ramadan Fasting in Type 2 Diabetic Patients: Comparison Between DAR Recommendations and the Carbohydrate Fasting Test & Metabolic and Inflammatory Consequences
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus, Type 2 Treated with Insulin
Fasting, Intermittent
Ramadan Fasting
Inflammatory Markers
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
Collaborators: name: Hopital La Rabta
First posted: 2025-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 70 years with Type 2 diabetes on a basal insulin regimen (NPH, Detemir, or Glargine) with or without 1 to 2 boluses of rapid-acting insulin.
* Diabetes duration of at least 2 years and insulin therapy for at least 6 months.
* Patients wishing to fast during Ramadan and having provided informed consent.
* Low risk of complications according to the IDF-DAR 2021 risk score or moderate risk for patients who insist on fasting.

Non-Inclusion Criteria:

* High-risk patients according to IDF-DAR 2021 score \>6, including those with:
* Severe renal impairment
* Cognitive dysfunction or frailty
* Unrecognized hypoglycemia
* Unstable cardiovascular disease
* Pregnancy
* Type 1 diabetes
* Type 2 diabetes patients on sulfonylureas or related medications

Exclusion Criteria:

* Patients who did not follow the study protocol regarding insulin dose adjustments and capillary blood glucose (CBG) self-monitoring.
* Fasting discontinuation without medical advice.
* Severe complications requiring fasting cessation.
* Patients who withdrew their informed consent.

Primary outcomes:
measure: fructosamine levels
timeFrame: up to 6 weeks
measure: Interleukin-6 levels
timeFrame: up to 6 weeks
measure: Hypoglycemia
timeFrame: up to one month
measure: glycemic auto-monitoring
timeFrame: up to one month
measure: HbA1c levels
timeFrame: up to 6 weeks
measure: TNF-alfa levels
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Body mass index
timeFrame: up to 6 weeks
measure: Quality of life of patients
timeFrame: up to 6 weeks
measure: waist circumference
timeFrame: up to 6 weeks
measure: Blood pressure
timeFrame: up to 6 weeks
Other outcomes:
Locations:
Study officials:
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