Clinical Research Directory

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

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.

Take the Reins: The Effects of Nutrient Timing on Cancer-related Fatigue

Cancer-related fatigue affects at least 30-90% of patients with cancer, depending on the type of cancer and their treatment(s) (e.g., chemotherapy, radiation). It is not relieved by sleep or rest, and it sometimes can persist for years after a person's cancer was treated. The fatigue can be so bad that people cannot return to work, hobbies, family roles, or other daily activities, thereby greatly reducing quality of life. The causes of this fatigue are unknown, and we currently do not have anything that can reliably prevent or cure the fatigue. However, there are recent data suggesting that circadian rhythm, or a person's internal body clock, may be disrupted by the cancer experience and contribute to fatigue. Food intake is an external cue that can entrain circadian rhythm. We recently showed that cancer survivors are willing and able to eat all their food within a 10-hour eating window-a practice called time-restricted eating. Herein, we are testing time-restricted eating against a control group (matched for time-, attention, and expectancy) to see if time-restricted eating can indeed alleviate cancer-related fatigue. All participants will be asked to use the myCircadianClock smartphone app to log their food intake and weekly body weight measurements. The participants assigned to the time-restricted eating group will be asked to eat all their food in a 10-hour window during the day. People can choose their start time based on their schedule and preferences, but we ask that the window is the same for the whole study (e.g., 7am-5pm,9:30am-7:30pm). Black coffee and unsweetened tea are allowed before the eating window, and water and medicines are allowed at all times. The participants in the control group will meet with a nutritionist to discuss the American Cancer Society nutrition guidelines in cancer survivorship; they will not be restricted to when they can eat. Participants in both groups will give us valuable information regarding how diet is related to the experience of fatigue. The purpose of this study is to test the effects of a 12-week TRE intervention vs. an unrestricted eating pattern on fatigue, the sustainability of the program at 24 weeks, and the effects of TRE on circadian rhythm and sugar metabolism.

Time-Restricted Eating to Address Persistent Cancer-Related Fatigue

This study will assess the feasibility of delivering a 12-week time-restricted eating intervention as well as the intervention's preliminary efficacy on persistent cancer-related fatigue among cancer survivors compared to a general health education control. Participants will be randomized 1:1 to one of two arms: time-restricted eating or control. Those in the intervention arm will self-select a 10-hour eating window in which to consume all food and beverages (water is allowed any time, black coffee and unsweetened tea are allowed in the morning). Both groups will receive weekly educational tips on healthy lifestyle behaviors in cancer survivorship. This study will also explore relationships between fatigue, circadian rhythm, and glucose metabolism. The hypothesis is that recruitment will be feasible, and participants will adhere to time-restricted eating and complete study activities over the course of the 12 weeks. The second hypothesis is that time-restricted eating will lead to less fatigue at 12 weeks compared to the control, accounting for baseline fatigue levels.

Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies

This study evaluates how lifestyle modifications that may be made to manage chemotherapy side effects in patients with gynecologic malignancies.